Audit Report - Part ED

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AUDIT REPORT
AUDITEE ABC Laboratories Pvt Ltd
AUDIT DATE(S) 07th & 08th August 2021
AUDIT CLIENT XYZ Healthcare Limited , UK
_____________________________________________________________________________________________________________________________________________________________________________________________________________________
NAME OF THE AUDITEE ABC Laboratories Pvt Ltd

Site Address: Formulations Division-Unit II,
Survey number -1821 to 1824,
Patancheru (Village & Mandal)
Sangareddy (Dist)-509228,
Telangana, INDIA
© Pha rmaso l U K Lt d. Un less ot her wis e spe ci fica ll y i nfo rme d /c om mu nicat ed, this rep ort s tan ds val id up to 2 ye ars fro m d ate o f issue
Type of products Finished Dosage forms: Sterile Injectables

manufactured
Key contact person at Mr.M.Krishna Prasad,
the site during the audit GM-QA,
: krishna_p@abclabs.com ; Mobile: 9432675471
AUDITING FIRM PHARMASOL UK Ltd.

Knight House,
364 City Road,
LONDON-EC8V 2NS,
United Kingdom
Auditor(s) Mr. T.Arun Prasad,
Senior GMP consultant (will be as the role of ‘Lead auditor’)
Mr. Pramod Kulkarini,
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GMP consultant (will be as the role of ‘Co- auditor’)
AUDIT CLIENT: XYZ Healthcare Limited

Address: Whiddon valley,
Barnstaple
EX 32 8NS,
Barnstaple,
UNITED KINGDOM
>> F o r a n y q u e r i e s / c l a r i f i c a t i o n s  i n f o @ p h a r m a s o l . c o m m e n t i o n i n g t he d o cu m e n t # < <

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Table of Contents
SECTION I -PREAMBLE
AUDIT OBJECTIVE............................................................................................................................................. 3
AUDIT SCOPE ..................................................................................................................................................... 3
AUDIT CRITERIA ............................................................................................................................................... 3
AUDITEE PARTICIPATIONS ............................................................................................................................... 3

SITE DESCRIPTION............................................................................................................................................. 4
REGULATORY HISTORY.................................................................................................................................... 4
SECTION II -EXECUTIVE SUMMARY AND AUDIT FINDINGS
EXECUTIVE SUMMARY ...................................................................................................................................... 6

NONCONFORMITIES OBSERVED ....................................................................................................................... 7
CLASSIFICATION BASIS FOR NON-CONFORMITIES ....................................................................................... 10
INTERPRETATION TO AUDIT CONCLUSION .................................................................................................... 11
SECTION III -GMP INSPECTION AND FACILITY TOUR
WAREHOUSE.................................................................................................................................................... 12
PRODUCTION ................................................................................................................................................... 15
QUALITY CONTROL INCLUDING MICROBIOLOGY LAB ................................................................................. 20
ENGINEERING INCLUDING UTILITIES............................................................................................................. 28
SECTION IV-QMS SET UP & DOCUMENTATION REVIEW ................................................................................. 33
SECTION V-AUDITOR’S PROFILE ....................................................................................................................... 48
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SECTION VI-AUDIT COMPLIANCE RESPONSE/ CAPA ....................................................................................... 49
SECTION VII-AUDIT CLOSURE STATEMENT ...................................................................................................... 50
SECTION VIII-NON-CONFLICT OF INTEREST DECLARATION .......................................................................... 51
APPENDIX -A-PERSONNEL ORGANIZATION CHART...................................................................................... 52
APPENDIX B-OVERVIEW OF SITE LAYOUT .................................................................................................... 53
APPENDIX C-SITE ACCREDITATIONS ............................................................................................................. 54

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SECTION I-PREAMBLE
AUDIT OBJECTIVE
The onsite audit was conducted in an open, friendly and unbiassed manner with an objective to evaluate
the level of compliance of M/s. ABC Laboratories Pvt Ltd against the standards as detailed in “Audit
Criteria”, including the specific areas/systems within GMP as requested by audit client.
AUDIT SCOPE
The product(s) covered under the scope of the audit were-
 Tranexamic Acid Injection BP 100mg/ml
 Lacosamide Injection
 Baclofen 2mg/ml Intrathecal injection
 Bimatoprost Eye drops
 Urapidil 5mg/ml Injection
Activities and /or processes applicable to following functions are covered during this audit.
 Buildings, Facilities & Utilities  Quality management
 Material management & controls  Documentation controls
 Production Processes & Equipments controls  Validation & Qualification
 Packaging & Labelling controls  Storage and Distribution controls
 Laboratory and Instrument controls  Personnel
X Any other(s):
AUDIT CRITERIA
The minimum requirements stated in the following guidelines were adhered during evaluation :-
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 Eudralex Vol 4. Part I-medicinal products X CFR.Title 21. Part 210, 211
X Eudralex Vol 4. Part II-Active substances X CFR.Title 21. Part 820
 Eudralex Vol 4. Part III-Related documents applicable annexes X ISO 15378:2017
 EU FMD (2011/62/EU) X PS 9000: 2016
X WHO GMP guide and applicable TRS X IPEC /EXCiPACT
X Any other(s):
AUDITEE PARTICIPATIONS
Following key personnel have been involved during the course of audit:
 Mr. Ranjit, Site Head
 Mr.M.Krishna Prasad, GM-QA
 Mr.Ram Reddy, Sr.Manager-QC
 Mr.Vignesh Patel, GM-Production

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 Mr. Kalrav Patel, Sr.Manager-Warehouse

 Mr. Prakash Alberque, GM-Engineering
In addition to above, many other personnel during the shop floor round, have been questioned to
interpret the practices followed during specific activities.
SITE DESCRIPTION
The site is well connected through road and is around 25 kms from Hyderabad International airport,
towards Bangalore highway. The total plot area of site is around 3.95 acres and the factory are situated
in a pollution free environment and surrounded by non-polluting industries, which do not generate any
smoke, soot or dust. There are no polluting chemical or pesticide manufacturing units in the vicinity.
The construction was commenced in Mar 2000 and was completed in Jan 2002, following which the
plant was commissioned in May 2002. The total built up area is approximately 8000 m2. The
production has following lines for manufacture of sterile dosage forms:
Line Sterile dosage forms Pack Configurations
Plastic Glass Glass Vials
bottles Ampoules
Line -I Ophthalmic & Injectables 5ml to 15ml NA 2ml to 30 ml
Line -II Ophthalmic/OTIC solutions only 5ml to 15ml NA NA
Line -III Injectable only NA 1ml to 10ml 3ml to 30ml
Line -IV Ophthalmic & Injectables 5ml to 15ml NA 2ml to 30 ml
Based on information provided, it is understood that the site is capable of manufacturing 2.5 million
ampoules/month and 4 million vials /month on a two-shift basis.
No toxic or hazardous substances are handled and/or processed at site.
The site employs ~1300 skilled personnel and number of employees in various departments are as follows.
Department/Functions E M PL OY E E S
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Quality Assurance 62
Quality Control 107
Microbiology 59
Warehouse 19
Production 207
Engineering including maintenance 46
Other departments (HR;IT; Project Management, etc) 14
Total number of employees 526
REGULATORY HISTORY
The finished dosage forms are manufactured, vide drug manufacturing license number 50 /MN /TS
/2014 /F /G issued by Drug Control Administration, FDA, Government of Telangana dated 25 Aug
2014, vide Form 25 & Form 28, as per Drugs & Cosmetics Rules 1945. The license has been renewed
on 26 Aug 2019 and the copy of same is enclosed in Appendix III.
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State authority (Drug Control Administration, FDA, Government of Telangana) and CDSCO (Central
Drug Standardization Control Organization, Ministry of Health and Family welfare, Government of
India) inspects the site at regular frequency to evaluate the level of GMP compliance. The most recent
inspection was conducted around Sep 2018. Various other certifications are as follows;
Country Agency Month & Year of inspection (Most Recent) Approval status
Hungary NIPN Dec 2019 Approved
USA USFDA Nov 2019 EIR received
PERU DIGEMID Aug 2019 Approved
UK MHRA Jul 2019 Approved

Gulf GHC Jun 2019 Approved
Czech Republic SIDC Apr 2017 Approved
Geneva WHO Mar 2017 Approved
Tanzania TFDA Dec 2016 Approved
Kenya MoH Sep 2016 Approved
Nepal MoH Jul 2016 Approved
Brazil ANVISA Jun 2016 Approved
Germany BGV Mar 2016 Approved
Note: Block II has been recently completed. Formal request for Inspection has been applied to
concerned drug control authority and awaiting inspection.
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SECTION II-EXECUTIVE SUMMARY AND AUDIT FINDINGS

EXECUTIVE SUMMARY
ABC laboratories Ltd was audited by two auditors representing from ‘Pharmasol’ for two full
business days. This was an onsite audit, to assess the level of compliance in Manufacturing, Testing,
Storage, and Distribution areas and systems by facility tours of different areas as well as review of
the SOPs and records.
All the personnel who interacted during the audit were appeared to be well versed with the activities
they have been assigned as well as on cGMP, as evident through the interviews, facility tour, and
review of training records.
All materials (APIs, Excipients & Packing materials) are procured from approved suppliers. The
warehouse areas are spacious and have separate spaces for storage of Raw materials, Primary packing,
and Secondary packing materials, and finished products. The areas within the warehouse are further
subdivided into segregated zones for Quarantine, Approved, and Rejected materials. Dedicated
cubicles are available for performing sampling and dispensing activities.
Upon receipt of the consignment, the containers are dedusted in a confined area. After dedusting and
satisfactory verification of relevant information, the containers are transferred to the Quarantine area
and GRN is prepared by warehouse personnel. Information to QC is given about the receipt of
material (by forwarding the GRN) and to initiate sampling activity. Upon receipt of GRN, the quality
control lab assigns an Analytical Reference number. In the case of API, all the received containers
are sampled for Identification purposes and a pooled sample from a representative amount of each
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container is taken for other Qualitative and Quantitative tests. Upon sampling, sampled labels are
affixed by QC personnel. Upon satisfactory completion of testing & after determining the compliance
with laid down specifications, the release of Raw materials and Packing materials is through ERP
system after which is material is designated to move to ‘Approved’ area.
The finished products are processed under a highly controlled environment and adequate controls to
minimize the risk of contamination. Primary and Secondary gowning procedures are in place. As a
measure for sterility assurance practices, media fill is performed at defines intervals. The processing
equipment are equipped with CIP systems, which provides adequate assurance concerning the
removal of residues. The vial filling area is equipped with an online particle counter for continuous
monitoring of Non-viable particle counts in the background area. The cleanrooms are controlled
through dedicated AHU to maintain differential pressure & provide required Air changes/hour for a
particular grade. Utility system includes:- Water system (Purified Water, Water for Injection), Pure
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steam generation; Compressed Air & N2 generation. Key processing parameters (such as mixing
time, sequence of addition, volume checks) are recorded in Batch Manufacturing Records,
contemporaneously.
QC lab is well equipped with sophisticated equipment like HPLC, GC, FTIR, UV. The microbiology
lab is equipped with a separate area for evaluating Sterility tests, MLT, and BET tests. Bacterial
identification and antibiotic susceptibility testing are through a fully automated system -VITEK2.
Approved procedures are available for Sampling, Testing, Evaluating the analytical data.
The site has semi-automated Packing lines, which can enable Tamper evident seals and embedding
serialization at carton & shipper level and further aggregation at pallet level. The activities related to
packing are governed through a master packing card. Packaging steps related to a particular batch are
recorded in the Batch Packing record.
Overall, there were no critical observations. However, there are 5 minor non-conformities were cited
during the audit. All the non-conformities were explained to the key personnel, during the closing
meeting and suggestions have been given for the way forward to bring necessary compliance. The
non-conformities have been agreed upon by the concerned.
The company was considered to conform to applicable EU GMP standards except for the non-
conformities detailed in the “Non-conformities” section below; upon receipt of the effective CAPA
plan from the auditee, this audit shall be closed and the closing statement shall be issued.
 Good Practices recognized
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Quality notifications are handled through software- Trackwise 
 Unresolved diverging opinions between audit team and auditee.
Nil
 Obstacles encountered during audit
Nil
 Areas within audit scope , however not covered during the audit
Nil
NONCONFORMITIES OBSERVED
The non-conformities observed during the audit are presented below

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Sr.# Details of the non-conformities Ref. clause and expectations Category

1 In the QC labs, the CDS (Chromatography Deficiency against MHRA GXP Data Minor
Data Systems) software Empower 3 is used Integrity Guidance and Definitions;
for HPLCs; During the review of the access Revision 1: March 2018.
and privilege standard procedure (IT/001) 5.1 Systems and processes should be
for the same it was noted the access levels designed in a way that facilitates
such as ‘Guest’ and ‘Analyst’ are not part compliance with the principles of data
of the procedure, while those are being integrity
used in the system.

2 During the review of the temperature Deficiency against EU GMP Vol 4, Minor
mapping report (GSP/Q/18/086) of the raw clause -5.7
materials store G-253; it was noted that the All materials and products should be
seasonal impact was not evaluated while stored under the appropriate conditions
performing the activity. [Note: It was established by the manufacturer and in
informed to the auditor that the site is under an orderly fashion to permit batch
process for implementation of the same and segregation and stock rotation.
standard procedure has been revised
3 During the review of the procedure for Deficiency against Annex 15, Clause Minor
Product Quality Review (QS/061), it was 5.24
understood that there is no systemic The method by which the process will
approach to perform the Continuous be verified should be defined. There
Process Verification of marketed drug should be a science-based control
products. strategy for the required attributes for
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incoming materials, critical quality
attributes, and critical process
parameters to confirm product
realization. This should also include
regular evaluation of the control
strategy. Process Analytical
Technology and multivariate statistical
process control may be used as tools.
Each manufacturer must determine and
justify the number of batches necessary
to demonstrate a high level of assurance
that the process is capable of
consistently delivering quality products.

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Deficiency against ICH Q10, 3.2.1
Pharmaceutical companies should plan
and execute a system for the monitoring
of process performance and product
quality to ensure a state of control is
maintained. An effective monitoring
system provides assurance of the
continued capability of processes and

controls to produce a product of desired
quality and to identify areas for
continual improvement.
4 During the review of the self-Inspection Deficiency against EU GMP Vol 4, Minor
procedure (QS/062) and its implementation Part-I, Clause – 9.3
following observations were made. All self-inspections should be recorded.
4.1. As per clause number 6.18 the annual Reports should contain all the
plan for the self-inspection needs to observations made during the
be prepared within the December of inspections and, where applicable,
the last year however for the current proposals for corrective measures.
year the self-inspection schedule was Statements on the actions subsequently
prepared and approved on 13th Jan taken should also be recorded.
2021; no rationale was recorded for
such delay.
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4.2. As per the clause 6.22 of the
mentioned procedure; during the
evaluation process of the trainee
auditor, the lead auditor is also
required to assess the observations
made by the trainee auditor.
However, in the actual scenario, there
is no provision made to identify the
observation made by the trainee
auditor. Therefore, it was not clear
how the evaluation process was
performed.

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5 During the review of Vendor Qualification Deficiency against EU GMP Vol Minor
documents following observations were 4, Clause – 5.29
made. Supply chain traceability should be
established and the associated risks,
5.1. The standard procedure (QS/013) of
from active substance starting materials
Vendor Qualification, clause. 5.10.2
to the finished medicinal product,
mentions to perform the routine
should be formally assessed and
evaluation based on the complaints,

periodically verified. Appropriate
OOS, rejections, audit outcomes, etc.
measures should be put in place to
However, it was noted that the audit
reduce risks to the quality of the active
outcomes were only considered as a
substance.
part of the evaluation.
Further audits should be undertaken at
5.2. The excipient risk assessment for the
intervals defined by the quality risk
Citric Acid Anhydrous
management process to ensure the
(F/QS/003/06/07) did not include the
maintenance of standards and continued
conclusion concerning the
use of the approved supply chain.
requirement of on-site audit; the
Excipients and excipient suppliers
respective section was left blank.
should be controlled appropriately based
5.3. Supply chain traceability of the
on the results of a formalised quality risk
Tranexamic Acid was available in the
assessment in accordance with the
document number SC/20/G2/01
European Commission ‘Guidelines on
however the document didn’t provide
the formalised risk assessment for
the details of the different modes of
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ascertaining the appropriate Good
transport along with logistic points
Manufacturing Practice for excipients of
during the entire transportation
medicinal products for human use’.
process.
CLASSIFICATION BASIS FOR NON-CONFORMITIES

The non-conformities noted during the audit are classified based on the following criteria.
Category Description / Definition
Critical Deficiencies with current regulatory expectations and/or company standards (which eventually
resulted a non-compliant product or would produce it) that pose an immediate significant risk
to Patient safety, Product Quality, Data Integrity (including misrepresentation/ falsification
/fraud) or a combination/ repetition of major deficiencies that indicate a critical failure of
systems. Immediate corrections and/or corrective actions are expected.

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Category Description / Definition

Major A deficiency or pattern of deficiencies that may result in the production of materials or
product not meeting specified requirements/ not comply with its marketing authorization or
may result in the delivery of a service not meeting specified requirements.
A combination of several “minor” deficiencies, none which on their own be major, but which
may together represent a major deficiency and should explained and reported as such.
Minor A departure from the quality system that is not considered Critical or Major and reflects
minimum regulatory non-compliance.
INTERPRETATION TO AUDIT CONCLUSION

Audit conclusion Definition
Satisfactory There is no evidence of non-compliance that would affect product/service quality,
patient safety, and/or regulatory compliance. There may be several major and minor
observations that should be corrected, however no critical observations
Caution Evidence of non-compliance is likely to have a moderate effect on product/service
quality, patient safety, and/or regulatory compliance; however, issues can be remedied
with corrective actions.
Unsatisfactory There is evidence of Critical non-compliance that could have a serious effect on
product/service quality, patient safety, and/or regulatory compliance.
LEAD AUDITOR
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Name : Mr. T.Arun Prasad,
Title : Senior GMP consultant
Pharma Sol Limited, UK
Dated: 30th August 2021

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SECTION III-GMP INSPECTION AND FACILITY TOUR
This section contains the summary of areas and/or systems inspected during the days of the audit.
Observations noted were presented in section II of this report concerning the respective deficiency
category. While inspecting, multiple records and/or reports (relevant to the area inspected and/or
activity performed in the specific area) are requested to the auditee(s) for evaluation. The records
and/or reports, presented, are evaluated objectively to determine the extent to which audit standards
are fulfilled. The outcomes of such records and/or reports are summarized in relevant sections of
each department. Also, as part of the shop floor round, interacted with the concerned personnel
involved in the activity, to interpret the actual practices followed. Specifically, activities such as
sterility testing, practices within aseptic areas have been deeply observed and documented in the
relevant sections, where appropriate.
WAREHOUSE
The warehouse is within the manufacturing block and various activities / systems available and/or
processes followed are as follows.
Material Receipt
All incoming raw materials and packaging materials are received by the warehouse department. The
receiving bay is found to be suitably designed with Air curtains and there is a provision for dedusting
the containers. Receipt of Raw materials & Packing materials is handled as per systemic procedure
WH/025. Reviewed the procedure and determined that, upon receipt of any consignment, before its
acceptance, the containers are physically verified for their identity and integrity /authenticity. The
verification also includes an examination of documents provided such as availability Manufacturer
CoA Material code against the approved vendor list, etc. This verification is substantiated through a
checklist. Upon examining the inward register, randomly requested the completed checklist for a
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Tranexamic Acid. Reviewed the material received checklist (vide format F/WH/025/01/12) for Batch
number X1903019M and found to be adequate. Observed that a QA approved vendor list is available
and found the material codes for following API’s
Name of the API Material Code Vendor Address
Tranexamic Acid RAP000434 Hunan Donting 16, Dongyan Road, Deshan, Changde city,
Pharma Co Ltd. Hunan Province, China PC415001
Baclofen RAP000458 Pol Pharma 19, Pelplinska street, 83-200 starogard
Pharmaceutical Gdanski Poland
Works
Bimatoprost RAP000322 Chirogate 41, lane 298, Gong 2nd rd and no. 22,
International Inc Alley 39, Wulin Village, Longtan township,
Taoyuan Taiwan 32559

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Name of the API Material Code Vendor Address

Lacosamide RAP000472 Indus Remedies ltd R-96/97, TTC Industrial area,
MIDC, Rabale, Navi Mumbai-400701.
Urapidil Not available, since as informed by the auditee, the project was dropped out
Material Segregation
After satisfactory verification, followed by de-dusting (in a confined area), the consignment
/containers are transferred to the Quarantine area of appropriate storage conditions, where applicable.
The (material) containers are segregated according to their batch numbers and are placed in pallets.
GRN is prepared and simultaneously information is given to QC, to plan for sampling activity.
Examined the copy of GRN vide number RG2100412 prepared for ‘Tranexamic Acid USP’ against
the batch number X2103013M. The GRN is adequate concerning its applicable and/or governing
procedural requirements. As informed by the auditee, in case, if any containers are received in
damaged condition, a separate sample is collected and tested separately.
Sampling area
The warehouse has 2 sampling cubicles, one for raw materials, other for packing materials. Each
cubicle has a separate entries for Man movement and Material movement. The cubicles are equipped
with reverse LAF and balances. Approved procedures are available for the Cleaning of sampling
cubicle. The details of balances & their operating ranges in the sampling cubicle are as follows
Sampling Cubicle dedicated for Cubicle dedicated for
cubicles Raw materials Packing materials
Cubicle ID G258 LAF ID: Q/113
Balance ID Q/218 ; Q/460 W/024
Operating range 100mg to 200 gm ; 20 g to 2000g 30g to 13 Kg
Reviewed the daily calibration record of balance (Q/218) vide format F/QA/065/05-01 and found it
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to be within the acceptable range. Reviewed the procedure vide WH/012 for ‘Cleaning and
sanitization of raw material dispensing area’ and found it to be adequate. As informed by the auditee,
it was understood that dedicated scoops are available for sampling API. The cleaning and storage of
dispensing SS scoops are as per WH/017. Upon review, determined that the following dedicated
scoops are available to products in the scope of the audit.
Name of the API Dedicated Sampling scoop ID
Tranexamic Acid STST015
Lacosamide SSST114
Baclofen BSST036
Bimatoprost SSST074
Urapidil Not available, since as informed by the auditee, the project was dropped out
Sampling process
The activities related to Inspection and Sampling of Raw materials are as per approved procedure
QC/001. A copy of the approved procedure(s) is available near to sampling /dispensing cubicle and

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is easily accessible. Reviewed the procedure and found that detailed statistical sampling plans are
indicated. Representative samples of the material are withdrawn by QC personnel as per the
sampling plans, number of samples drawn is √𝑛 +1 , where ‘n’ is the number of containers. If a
consignment /batch is having less than or equal to 5 containers, all containers are sampled.
Upon sampling, the QC personnel affixes the ‘Sampled’ labels on the containers from which the
samples have been withdrawn. The details of sampling such as the number of samples withdrawn,
sample quantity, and the signature of the person who carried out the sampling and date of sampling
are documented appropriately. Different status labels differing in color schemes are being used (i.e.)
under test (Yellow) , Approved (Green) and Rejected (Red) status.
Material storage
The approved RM storage area has adequate space to accommodate containers of various sizes. The
RM storage area & dispensing areas have an epoxy coating. As part of the audit review, the
Temperature mapping report (vide GSP/Q/18/086) of the raw material storage area (G253) has been
examined. Upon review, it was recognized that seasonal impact was not taken into consideration
while performing the study. The auditee explained that site is under the process of implementation.
Informed the regulatory requirements and explained the conditions required to be established by the
manufacturer. Refer Non-conformity 2
Packing Materials:
Packing materials are segregated from raw materials and are placed on the second floor, to avoid any
mix-ups and cross-contamination. Inspected the storage cabinet, where printed labels are held, and
found that the cabinet is under lock and key. Examined, roll Label of Tranexamic acid Injection (Item
code; 3092) F1 SE 5ml (Vide code P2F100011) and found to be adequate concerning its last usage
record. A separate area for sampling and dispensing packing materials are available, with similar
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controls of raw materials as detailed above.
Rejected area
As observed, there is a separate zone for (temporary retention of )Rejected materials. The zone is
with provisions of Lock and Key. Based on interaction with the auditee, it was understood that the
rejected materials are handled as per approved procedure. Any material that is found to be Non-
conformance to the approved specifications is rejected and returned to the supplier at the earliest
possible time.
Finished goods warehouse
The finished product warehouse is available as a completely segregated area, where finished goods
are transferred for storage after packaging. The area is maintained in a locked condition, when not in
use to avoid any unauthorized entry. Upon satisfactory completion of testing and review of data, the
finished goods are transferred to a segregated zone within the warehouse. Finished Goods warehouse

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person verifies the batch release certificate approved by QA and verifies the number of finished goods
received.
Observed, two Cold chambers [W/056 & W/057] for storage of Temperature-sensitive finished
products. Reviewed, Temperature mapping study report vide # RVP/W/057/02, dtd 22nd Jun 2021
found to be adequate. The maximum temperature observed was 6.8°C against the range of 2 to 8°C.
Based on interaction with the auditee, it was understood that, Pallet level aggregation is done at the
Finished product warehouse using the Track and Trace platform -EUTOPIA. The script information
generated as part of pallet level aggregation is shared to 3PL logistics provider-TRACELINE. On

day_1 (around 11 hrs) of audit, there was no activity concerning palletisation. The finished goods are
stored batch-wise on pallets till dispatch.
PRODUCTION
In general, the Premises have been well designed keeping in mind;- Adhering to cGMP requirements
and considering the Best industry practices. The ceilings, walls and doors in the manufacturing areas
are found to be of modular construction. Ceilings are found to be with a smooth finish. It was
recognized that the buildings have been designed to facilitate Cleaning, Maintenance, and handle
appropriate operations to the type and stage of manufacture. The flooring for the Production is found
to be with the epoxy coat. The fixtures in ceilings such as Lights, Air outlets, are designed to minimize
dust accumulation and to facilitate cleaning. The view panels are double gazed. Based on discussion
with the auditee, it was understood that products in scope of audit are manufactured in following lines
Line (s) Name of the product (s) Status
Line -I Lacosamide Injection Not yet approved
Urapidil 5mg/ml Injection Dropped
Line -II Bimatoprost Eye drops Not yet approved
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Line -III Tranexamic Acid Injection BP 100mg/ml Commercialized
Line -III & Line IV Baclofen 2mg/ml Intrathecal Injection Not yet approved
Classified area:
Based on the review of the Layout plan presented, it was understood that design was appropriate &
infers a logical flow of material and personnel within the facility. Specifically, the critical areas are
found to be in Class A with a single access to prevent the space from being a pathway to others. The
operation conditions and background conditions for the various areas are as follows
Area Conditions under which Background
operations are carried out condition
Filtration area of ampoules and vials Grade A Grade B
Filling area of vials
Filling/Sealing of ampoules

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AUDIT REPORT
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Area Conditions under which Background

operations are carried out condition
Solution preparation area of ampoules & vials Grade A Grade C
Dispensing areas Grade A Grade D
Sampling areas
Washing of Ampoules & Vials
Upon review of the AHU grading zone, it infers a pressure cascade from the Highest grade (A) of
cleanliness to the Lowest grade (D). Based on the review of the HVAC layout presented, it was
understood that all the areas in the sterile facility are classified, either as Grade A/B/C/D to meet the
applicable requirements. As observed, the Δ Dpa is maintained NLT 16 Pascals between rooms of
different grades.
The filling areas (of Line-I, Line-II & Line -III) are equipped with an online particle counter for
continuous monitoring of Non-viable particle counts in the background area. The filtration area of Line-
IV is equipped with an online particle counter. Also, an Automatic Leak testing machine is installed
for product filled in Plastic bottles (i.e.) Line -I, Line -II, and Line -IV. An automatic inspection
machine is installed in Line -III.
The list of major processing equipment in Line-I and their capacities are as follows:
Major Equipment in Line _I Make Capacity
Manufacturing tanks Adam Fabriwerk 300 Ltrs (2 numbers)
Steam sterilizer Pharmalab 1215 Ltrs
Post sterilizer Pharmalab 2160 Ltrs
Ampoules/Vials washing machine Klenzaides 3 to 30 ml glass vials ;
5 to 15 ml for plastic bottles
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Ampoules/Vials Depyrogenation Klenzaides 3 to 30 ml glass vials ;
tunnel 5 to 15 ml for plastic bottles
Vial filling & sealing machine ROTA 3 to 30 ml glass vials ;
On the day(s) of the audit, there were no activities/operations in progress in Line-I.
The list of major processing equipments in Line-II and their capacities are as follows:
Major Equipment in Line _II Make Capacity
Steam sterilizer Pharmalab 2160 Ltrs
Vial filling & sealing machine Capmatic, Canada 5 to 15 ml for LDPE vials
On the day(s) of audit, there were no activities/operations in progress at Line-II.
The list of major processing equipment in Line-III and their capacities in Line-III line are as follows:
Major Equipment in Line _III Make Capacity
Manufacturing tanks Adam Fabriwerk 300 Ltrs (2 numbers)
Pre Steam sterilizer Pharmalab 2000 Ltrs

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AUDIT REPORT
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Major Equipment in Line _III Capacity Make

Post steam sterilizer 1500 Ltrs Pharmalab
Ampoules/Vials washing machine 1 to 10 ml for ampoule; ROTA
3 to 20 ml for glass vials
Depyrogenation tunnel ROTA 1 to 10 ml for ampoule;
Ampoule/Vial filling & sealing machine ROTA 1 to 10 ml for ampoule;
Sealing machine ROTA 3 to 20 ml for glass vials
Also observed that, an Automatic Inspection machine is installed exclusively in Line-III.

The list of major processing equipment in Line-IV and their capacities are as follows:
Major Equipment in Line _IV Make Capacity
Manufacturing tanks Adam 100 Ltrs
Steam sterilizer Fedegari 1265 Ltrs
Post sterilizer Pharmalab 2160 Ltrs
Ampoules/Vials washing machine Romaco 3 to 30 ml glass vials ;
Depyrogenation tunnel Romaco 3 to 30 ml glass vials ;
Ampoule/Vial filling & sealing Romaco 3 to 30 ml glass vials ;
machine 5 to 15 ml for plastic bottles
On the day(s) of the audit, there were no activities/operations in progress in Line-IV.
Empty vial decartoning area:
Observed the area, where empty vials are decartonned and visually inspected for any cracks or defects.
The area is found to be with adequate lighting and illumination. All those activities related to
“Decartoning, disinfection and transferring of primary packing materials from decartoning area to
filling area” is as per procedure P/046. Reviewed the procedure and found it to be adequate.
Vial washing area:
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The empty glass vials are first externally washed (in the Grade D area) with purified water. After
external wash, the vials are internally washed with WFI with aid of a Rotary vial washing machine.
Subsequently, the vials are sterilized, through a depyrogenation tunnel, which is at 300°C. The time
for depyrogenation is at least 2 min. Post depyrogenation tunnel, there is a cooling chamber, where
the temperature of vials is attained to ambient temperature. As informed by the auditee, the rotary vial
washing machine and depyrogenation tunnel are qualified for the specific vial size(s) generally during
trial batches. Reviewed the procedure vide P/115 “ Transfer of Sterilized articles to filling /filtration
area from autoclave” and found it to be adequate.
Interpreted the actual practices (through interaction with concerned personnel) and Reviewed the
procedure for “operation & cleaning of ROTA ampoule and vial washing machine ’ vide procedure
number P/229 and found to be following actual practices. As informed by the auditee, the ampoule/vial
washing machine is periodically maintained through an approved preventive maintenance schedule.
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Vial filling area:

Reviewed the systemic procedure MI/064 “Monitoring of critical areas for anaerobic microorganisms.
Reviewed the overall summary report for Environmental monitoring of the year 2021 (to the vial
filling area-line III). The maximum observed TAMC value and the details are as follows;
Type of monitoring Max TAMC Observed (for Jan to Jun Acceptance Limits
2021) in vial filling area-line III
Air sampling method NIL < 1 cfu/m3
Settle plate method NIL < 1 cfu/plate
Also reviewed the overall summary for Grade B areas of filling line-III &the observed values are as
Type of monitoring Max TAMC Observed (for Jan to Jun 2021) in Grade B areas of
vial filling area-line III
Air sampling method 11 cfu on 05th Jan 2021 (ENV/21/0014)
Settle plate method 46 cfu on 28th Jan 2021 (ENV/21/0180)
Reviewed the Re-qualification document for filling lines vide report numbers;

RVP/E/288/04 (For Line-I) , dated 21st Jun 2021

RVP/E/195/16 (For Line-II) , dated 11th Jun 2021
and found that Air changes per hour is found to be around 340 & meets applicable requirements of
Grade A classification in both ‘At rest’ and ‘In-operation’ as indicated in Annex 1 of EU GMP. The
video footage of the smoke study (depicting the airflow pattern) is found to be satisfactory.
Reviewed Process validation protocol (vide number PVRM/TCO/G2/0.3M/01 dated 29 Nov 2019) of
Tranexamic Acid Injection & understood that the process flow is as follows;
Collect WFI in 300 ltr manufacturing tank . Allow 1.pH 5.0 to 7.0
WFI it to attain temperature in range of 25 to 28°C. 2.Temperature 25 to 28°C
Flush with nitrogen till the dissolved oxygen is 3. Dissolved Oxygen < 2mg/ml
2mg/ml 4. TOC NMT 0.5mg/ml
5. BET: < 0.25 EU/ml
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After release from QC and micro transfer of WFI Conductivity < 1.3S/cm
WFI from manufacturing tank to 100 L pressure vessel
for rinsing and final volume make up
1. Stirring speed 200 rpm

Add Tranexamic Acid to WFI (in 300 Ltr tank)
Tranexamic 2. Stirring time 30 minutes
under stirring. Continue the stirring for 30
Acid 3. Clarity : Clear solution
minutes or till clear solution is obtained.
1. Stirring speed 200 rpm

Make up the volume upto the desired mark using
2. Stirring time 15 minutes
the WFI from 100 L pressure vessel under
3. pH 6.5 to 8.0
continuous stirring.
4. Clarity : Clear solution
Sterile filtration from 300 Ltr manufacturing tank 1. Pre BPT for WFI: NLT
to filling vessel through 0.2m filter 50.0 psi
2. Post BPT for Product :
NLT 47.41 psi
>> FFill
o r a nthe
y q filtered
u e r i e s / c l asterile
r i f i c a t isolution
o n s  i n in
fo@ p h a r m a s o l . c o m m e n t i o n i n1.g tNitrogen
ampoules he d o cu m eflushing
nt # <<
through
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Page 18 ofampoule)
54
3. Sealing height (5ml ampoule)
4. Sealing quality
5. Visual Inspection of filled
AUDIT REPORT
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Understood the process of manual visual inspection of Injectables, is as per systemic procedure P/233
and determined that Rejects are classified as follows;
Critical Rejects: These rejects can cause serious adverse reactions or death of the patient if the
product is used. This reject includes any non –conformity that compromises the integrity of the
container and thereby risks microbiological contamination of the sterile products
Major Rejects: These rejects carry the risk of temporary impairment of medically reversible reaction
or involve a remote probability of serious adverse reactions These rejects are also assigned to any
defects, which causes impairment to the use of the product. These may result in a malfunction that
makes the product unusable.

Minor Rejects: These rejects do not impact product performance or compliance they are often
cosmetic in nature, affecting only product appearance or pharmaceutical elegance
Typical AQL range % for visual inspection process is as follows;
Defect category AQL range (%)
Critical 0.010 – 0.10
Major 0.10 – 0.65
Minor 1.0 to 4.0
The types of defects, indicated in the governing procedure are as follows ;
 Foreign particulate matter like glass particles, black particles, white particles, fiber particles,
and any other particles.
 Improper sealing (Sunken tips; Bulbous tips; Crack Tips; Leaking ampoules; Pinholes)
 Missing identification marks (Snap cut, etc)
 Empty ampoule
Visual Inspection:
All personnel involved in visual inspection activity are qualified as per approved procedure, which
includes defective identity challenge study and optical test. Reviewed the Qualification record of the
Visual inspectors, Mrs. Pradnya Dicholkar (Emp. Code.26631), and Mr. Akshay Khot (Emp code
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034531) and found they are adequate. After completion of visual inspection, the good vials are
considered for labeling followed by packing activities.
Batch Initiation:
As informed by the auditee, based on the production order, the batch number is assigned by QA. The
transferring of dispensed raw materials, sterile raw materials from dispensing area to manufacturing
area is as per procedure P/002. Simultaneously, the batch documents (photocopy of Master BMR &
Master BPR) are issued. After ensuring that area & equipment are adequately cleaned as per approved
procedure(s), the Production personnel informs to QA department for clearance.
Re-examined the CIP cycle record for 300 ltrs manufacturing tank of Line III. The cycle record
generated by the system has information related to the name of the solvent used, temperature, time
used for cleaning the vessel. The CIP cycle record is found to be adequate.

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The QA personnel visit the shop floor and visually inspects the area & equipments. After ensuring the
adequacy of cleaning and availability of other pre-requisites (such as an Issued copies of BMR, etc)
the QA personnel issues the line clearance for initiation of the batch.
As informed by the auditee, all the processing activities are recorded in BMR. If any activities are
equipped with an automated system (such as NVPM), printout of the same is withdrawn from the
system and enclosed as an attachment to BMR. Activities related to packaging are recorded in BPR.
are recorded in BPCR and reviewed by production as well as by QA before clearance of finished
product to distribution. Batch Release of finished goods is as per procedure QA/071.
Reviewed the complete batch manufacturing record of Tranexamic Acid (Batch # TCO9KA2). The
compiled BMR is adequate with all necessary attachments. Re-examined the system generated
printouts for filter integrity check and determined that the bubble point pressure for Pre-Integrity and
at Post integrity is satisfactory. The observed values of Critical Process Parameters (mentioned in
BMR) are within the acceptable tolerance range or acceptable limits as indicated in the process
validation report. Also verified the NVPM data from the particle counter and found it to be within the
applicable limits. Verified the traceability certificate of the counter and determined that, it has been
calibrated against a (master LSAPC)device that meets the requirements of ISO -21501-4 norms.
Based on the procedures followed, the process flow of the product, outcomes of documents presented
for review, the production is capable to perform the manufacturing activities of products in the scope
of the audit.
Packaging:
Visited the packing section and recognized that no primary packing activities are in-progress, on the
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day of audit. Also , the auditee informed there is no plan for 24th Jul 2021
As informed by the auditee, all the packing lines can incorporate serialization as per customer-specific
and/or country-specific requirements. The Track and Trace platform available is EUTOPA. The
generated serial numbers (including the pallet level aggregation) can be uploaded to 3PL and/or EU
HUB platforms, to have a track and trace approach for each batch of a drug product. As a measure to
recognize tampering an ATD sticker is affixed on both flaps of carton.
QUALITY CONTROL INCLUDING MICROBIOLOGY LAB

QC laboratory is located independent from the manufacturing area, where all the analytical testing
(Physical, Chemical-Wet analysis & Instrumentation) is performed. The QC is capable of analyzing
of Raw materials, finished goods, Water analysis & Environmental samples. The QC is having
separate areas for the Chemical storage room, Instrumentation Lab, Balance Room, Purified water
generation (for QC utilization), Hot Zone, washing room, etc.

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The list of major instruments present within QC & their make are as follows:
Major analytical instruments in QC Total numbers Make /model
HPLC/UPLC with UV/PDA/RI detectors 33 Waters; Agilent ; Shimadzu
Gas chromatographs with HS & Liquid injectors 04 Agilent ; Perkin Elmer
UV spectrophotometer 02 Shimadzu
FTIR 01 Shimadzu
Analytical Balance 12 Sartorius ; Radwag
Particle Size Analyser 02 Malvern

Coulometer/Auto Titrator /KF-Titrator 01 Metrohm
Viscometer 02 Brookfield
In addition to the above analytical instruments, there are other ancillary instrumental aids /accessories
such as Refrigerator, UV cabinet, Ultra sonicator, Hot plate, Dry boxes, Vacuum pump, Magnetic
stirrers and Heating mantles with the regulator, etc. As informed by the auditee, the practices within
the QC lab are governed through the approved procedures for the various scope of activities.
Weighing Balance Room:
The QC is equipped with analytical balances including a microbalance. As observed, the Balances are
placed on an anti-static table along with an anti-vibrant pad. Two numbers of E2 class analytical
masses are available for daily calibration purposes. The balance is calibrated daily before usage. The
standard weights covering the range of balance is accounted for daily calibration. The monthly
calibration parameters include Accuracy and Repeatability. Verified the daily calibration record of
balance Q/274 and found it to be following applicable procedural requirements. Also determined that
daily calibration was performed by Ms. Swaroopa Veup (Emp code 032837). Hence verified the
training record and found that she has been trained to the current version of sop QC/197; QC/186;
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Q/102
Sample management:
Upon receipt of any sample, the person responsible or delegated to receive the samples ensures the
intactness of the sample, sample label, test request form, etc. After satisfactory verification, the
analytical reference number is assigned. Based on priority, the laboratory manager/supervisor allocates
the sample to the analyst(s) for specific parameters. Upon successful completion of data review, the
samples are discarded as per systemic procedure QC/091 “Disposal of laboratory waste’. Overall, the
sample management approach was found to be satisfactory.
Reagents and solvents:
Reagents and Volumetric solutions are governed as per approved QC/008 and QC/007 respectively.
As informed by the auditee, few reagents (such as KF one component titer) are directly procured for
external sources. The reagents/solutions prepared in-house are assigned with an expiry period. The
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expiry dating is assigned as 2 years for liquid after opening the container seal for the first time or the
expiry indicated by the manufacturer, whichever comes earlier. Special attention is paid to the
sensitive materials such as which are oxidizing in nature-Silver Nitrate (AgNO3) and a reduced expiry
of 6 months is provided for such materials.
Analytical standards
Activities governing working standards are as per procedure QC/140 “ Qualification of Working
standard”. As observed, all reference standards are kept as per their recommended storage conditions.
Unless otherwise indicated, the reference standards are stored in refrigerator 2-8C. The refrigerator
is under controlled access through user Id and passwords. Before actual usage, the standards are kept
in a desiccator for a while to attain room temperature. Reviewed the WS Qualification documents for
Tranexamic Acid (WS/TA-E/004) and Bimatoprost ( WS/BM-S/004). The qualification approach
followed, including the final ‘As is’ value is found to be in accordance with the procedural
requirements.
Instrumentation and calibration:
The QC is well equipped with analytical instruments such as HPLC, GC-HS, UV-VIS
spectrophotometer, FTIR. Activities relating to integration during chromatographic processing is
governed as per systemic procedure QC/219 Good Chromatographic Integration practices. The mobile
phases for liquid chromatography are prepared in a dedicated area. The receipt and handling of
chromatographic columns are as per procedures QC/158 & QC/019.
The instruments are calibrated through a pre-determined approved schedule. Approved procedures are
available for ‘Operation and Calibration’ of various Instruments .
Reviewed the Quarterly calibration record of the Gas Chromatograph (Q/216) dated 14th Jun 2021 and
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found it to follow applicable procedural requirements. Also determined that calibration was performed
by Ms. Archana Reddy (Emp code 028104). Hence verified the training record and found that she has
been trained to the current version of sop QC/177; QC/152.
Wet laboratory:
The wet lab is equipped with necessary instruments such as a pH meter, water bath, UV cabinets, and
associated instruments which enables the QC to perform complete testing. All the activities within the
wet lab are governed through various approved procedures.
Reviewed the following procedure and found it to be adequate.
 QC/136 – Laboratory Safety Practices
 QC/091- Disposal of laboratory waste.
The QC is equipped with an auto titrator integrated with Potentiometer. The lab is also equipped with
a Karl Fischer titrator for determining moisture content, which is placed in a cabinet to avoid
interference from the environment.
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Computerized systems – access control and audit trails:

The access control & password policies are well defined to all computerized systems within the QC
department. The rights of administrator level, method developer, and analyst level are well defined to
avoid unauthorized access. The assignment of the user ID is as per approved procedures. Based on
interaction with QC head, it was understood that all the HPLC/UPLC instruments are integrated with
Empower 3, chromatographic data system.
Each individual working in QC is assigned with a user account to work on the computer system-based
instruments such as HPLC, GCs, IR, etc. The user account is specific to everyone with a unique user
ID and password. During the review of system settings (for Empower 3), a discrepancy was observed
& it was understood that there are two additional user groups available in the software such as ‘Guest’
and ‘Analyst’ which were not included in the governing procedure (IT/001). Refer Non-conformity-
1
Different user access levels are assigned based on the roles and responsibilities and defined in the
document; such different hierarchy of access levels are QA, Analyst, QC reviewer, Service engineer,
manager, IT admin, etc. IT is the admin here and assigned with the highest level of access privileges
including assigning/modifying the access to other users. As confirmed to the auditor, no one having
the access to delete any data.
As informed by the auditee, the audit trail generated as part of the chromatographic analysis is verified
as part of analytical document review (also as & when necessitated). It was understood that all
computer system-based instruments are enabled with audit trails which records any modifications
made to the data/system parameter during/after analysis. None of the personnel are able to delete the
audit trails data as depicted in the procedure for privileges. The review of audit trails is performed as
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a part of the analytical data review for every batch before batch release.
Data back-up:
As informed by the auditee, Primary disaster recovery data backup of QC instruments is automatically
transferred from server to Portioned drive as per the set scripts program. Secondary disaster recovery
data from NAS drive to tapes are taken on a daily and weekly basis. Back up of electronic data (through
Hot & Cold scripts) is performed through software. All those activities related to electronic data
management are governed as per QC/175 “Data management system”. Also, there is a standard
practice of data restoration and verification on yearly basis.
As part of the review, the log of verification for backup data for FTIR from 12th Jul to 16th Jul 2021
was reviewed and found to be adequate. Also verified the validity of Polystyrene film (SRM 1921b)
and found to be valid until 31 Dec 2021.
Testing/Analysis
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Allocated samples are tested/analyzed as per (QA) approved standard testing procedures. Test
procedures for Raw materials are transcribed from the current edition of applicable Pharmacopoeial
monographs. Test procedures for finished products are generally based upon after successful
completion of method transfer to site, as per systemic procedure QC/212. Additionally, the feasibility
of analytical methods (of Pharmacopoeial monograph test methods) is evaluated as per systemic
procedure QC/261.
Laboratory Incidents:
Any incidents, while testing is handled as per systemic procedure QC/178. Reviewed the trend
laboratory incidents for the review period Jan to Jun 2021. For the incidents, which have been closed
the summary or errors are classified and the details are as follows;
Q1 Q2
Jan to Mar 2021 Apr to Jun 2021
Analyst Error 26 30
Instrument Error 22 15
Analytical Error 29 20
Documentation Error 03 09
Software Error 08 04
Other types including Random and/or atypical errors 10 21
Inference : When enquired for (No drop-in Analyst error) the QC head conveyed, during pandemic
season, there was significant drop in Analyst head counts, which eventually resulted in overloading to
existing personnel. Also assured, now sufficient manpower has been induced and expected to reduce
the Human errors in the upcoming quarter(Q3).
The review also infers that the majority of incidences that occurred during the review period were
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completed within the timeline provided (within 20 working days) and the remainder were completed
within the approved extended timeline. Among the classified incidences, those grouped into the
‘Others’ category were found in the majority with least being direct Documentation errors. A Human
error form was issued and thoroughly handled to find out the actual cause for such incidences.
Incidences that were closed keeping CAPA open are being monitored.
Reviewed the OOS trend evaluation for Q1 & Q2 of 2021. The outcomes of evaluations are as follows.
Trend evaluated period Number of In-validated OOS Number of Validated OOS
Q1 (Jan to Mar 2021) 12 11
Q2 (Apr to Jun 2021) 14 08
Reviewed the OOT trend evaluation for Q1 & Q2 of 2021. The summary of the review is as follows
Trend evaluated period Number of In-validated OOT Number of Validated OOT
Q1 (Jan to Mar 2021) 04 03

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Q2 (Apr to Jun 2021) 02 05

Finished Product Specification:
Finished product specifications are prepared (and updated) in accordance as per ICH Q3B (R2)
guidelines. The specifications include control of degradation impurities and unknown impurities.
Based on the review of CoA of the batch (TCO9KA2) the observed value of impurities is well below
the Identification threshold, as indicated in the guideline.
Electronic data Review:
After successful completion of the analysis, the generated electronic data are reviewed for its accuracy
& adequacy as per systemic procedure QC/218, and further evaluated for its compliance against
approved specifications.
Stability study management:
Stability study management is as per systemic procedure QC/016. As part of stability evaluation,
Critical Quality Attributes are compared at appropriate intervals against the initial values and/or
historical data in order to recognize any changes to the drug product. As per the procedure, apart from
the standard stability sample analysis requirements due to process changes, a system of annual addition
of one batch is in place.
While performing an inspection to stability chamber area, observed a list of personnel authorized to
access stability chamber. Also noted that the entry is restricted, and the concerned personnel shall
provide his/her credentials through an (HMI) input interface, which is kept near to the chamber door.
The annual addition batch selection is performed from any first 10 batches of the corresponding year.
Reviewed stability protocol for a commercial batch TCO1AC2 of Tranexamic Acid Injection (MFG
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date: JAN 21 EXP date: DEC 22) and found to be adequate.
Various stability chambers are available to incubate the samples in different temperature/RH
conditions. Below are different conditions available at the site:
Study /Evaluation Conditions
Accelerated stability study Temperature: 40  2°C ; Relative Humidity 75  5%
Long-term stability study Temperature: 25  2°C ; Relative Humidity 60  5%
Intermediate condition Temperature: 30  2°C ; Relative Humidity 65  5%
Temperature sensors are exposed inside each chamber for temperature/RH monitoring and data is
recorded in the computer system. The system records reading on an hourly basis and is verified on
daily basis. The alarm is linked with the sensors and goes off in case of any excursion in the readings;
hooters are connected to the QC and security areas and both the departments are working 24/7. The
alarm challenge test is performed on yearly basis.

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Stability Chambers are annually calibrated by the Original Equipment manufacturer using devices,
which are traceable to National standards. The yearly calibration also includes temperature mapping.
It was confirmed that the vendor performs the calibration of sensors and the chamber qualification and
there are NO deviations/incidents related to stability chambers.
Microbiology laboratory:
The Microbiology laboratory is located on the second floor of the annexed building. The micro lab is
separated from the regular chemical analysis lab area and can perform all the microbiological method
validations for sterility test, bacterial endotoxin test, microbial enumeration test, and test for specified
microorganisms. All the analysis is carried out as per the approved/validated Standard/General test
procedures and Standard operating procedures. The microbiology lab is equipped with the necessary
instruments and equipment to analyze the microbial attributes of Raw materials, Excipients, finished
products, Stability samples, packing materials, Environmental monitoring of manufacturing areas, and
water analysis of Water for injections, Purified water, Pure steam condensate, and Treated water.
As observed the critical areas such as microbiological testing rooms along with respective change
rooms are provided with separate AHU and the non-critical areas such as the Incubation room,
washroom, and media preparation are provided with AHU’s. The areas catered by AHU are maintained
at a temperature not exceeding 25°C, with air changes of 30 / hour. The entry and exit to the sterility
testing area are through series of change rooms. The list of major instruments available within the
microbiology lab & their make is as follows:
Major instruments in microbiology lab Total numbers Make /model
Steam sterilizer 02 Pharmalab
Vitek 2 compact system 01 Biomerieux
Incubators 16 Thermolab
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Cooling cabinet 01 Thermolab
Walk In chambers 04 Thermolab & Newtronic
LAF work stations 07 Esco
Bio safety cabinets 03 Esco
Filter Integrity machine 01 Advanced micro devices
Vertical auto clave 02 Equitron
Particle counter 01 Amil
Reviewed the procedures M/143 and M/144, which detail the Cleaning and Sanitization of
Unclassified and Classified areas of the Microbiology lab. Understood the disinfectants used and
rotation frequency are as follows;
Name of disinfectant Rotation frequency Applicability
2% Bacilloid special Weekly Mopping and Fogging

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0.4%Virex II 256 Weekly Mopping

3% Minncare Weekly Fogging
The Doors and glasses/ S.S Furniture are mopped with a clean cloth wetted 70%IPA.
Microbiologists are employed to carry out various testing for water samples, environmental
monitoring, and API testing (if necessary). Microbiologists are trained as per sop MI/140
‘Qualification of an analyst in Microbiology lab’. Reviewed the systemic procedure. The qualification
approach is as follows; Based on previous experience ( minimum 2 years ) and understanding the
Microbiology head, identify/nominate a particular analyst for the qualification process. The
qualification is performed on media fill containers and if media fill vials are not available, the
validation shall be performed on a released lot of peptone water as mentioned in the procedure (which
mentioned collect 80 numbers of media fill samples or issue 4 X 100 mL released aliquot of sterile
peptone water used for sterility testing (Closed method). Four test samples from the above collected
sterile Sample are prepared, one for Section Head and another three for analyst under qualification.
Negative control of the test shall be performed with 100 mL of 0.1% peptone water separately. Further,
Performance of testing by Section Head: Perform the sterility test of a given sample as per SOP No.
MI/013 or MI/101.Performance of testing by analyst under qualification: The Section head should
provide the samples to the analyst under qualification. Perform the sterility test as per SOP No. MI/013
or MI/101.Observe the result on daily basis on the respective analyst qualification protocol.) Records
of training are documented in the file of an analyst. Reviewed the microbiologist qualification record
of Mr. S. Mahesh vide report # AQ/ST/035334/01, found to be adequate and in compliance with the
governing procedure.
Microbial cultures are procured from reputed institutes (which provides certificates indicating the
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strain number, Response factor, transportation conditions, etc) in the lyophilized state which are
ATCC or equivalent strains. The microbial cultures are stored in 2 to 8°C. The number of passages for
each reference culture is not more than 4. The activities related to Microbial cultures are handled as
per MI/007’Maintenance of microbial cultures by seed lot culture maintenance technique’. Verified
the usage record for Aspergillus brasiliensis (ATCC16404) and found it to be adequate.
There is a separate media preparation room to prepare the media from de-hydrated media purchased
from approved suppliers “Hi-media”. The preparation and storage of Media are as per standard test
procedure or as per monographs. The autoclaves are qualified for different loading patterns and cycles
including empty and fully loaded conditions for the sterilization; yearly re-qualification is carried out
for the autoclave. Reviewed the Media preparation details of BSCP for batch MED/0909/21. The
autoclave cycle record 11455 was available with the necessary details. The growth promotion test (for
the above media) was initiated on 17th Jul 2021 and released for usage on 23rd Jul 2021. The quantity

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released for usage is 26 ltrs. Reviewed the re-validation report of Incubator (Q/308) vide report #
RVP/Q/308/03 and found it to be adequate.
GPT (Growth Promotion Test) is performed after media preparation to ensure the media is capable
to promote growth as expected. Randomly reviewed GPT for media MPY 0175 dated 21 Oct 2019
and found to be adequate. Also, the reconciliation details are satisfactory. Prepared media is stored in
an incubator; Incubators are available with different incubation conditions are available to be utilized
including one stand-by. Yearly calibration of each incubator is carried out as per schedule. The
disposition of used media is as per approved procedure M/108.
ENGINEERING INCLUDING UTILITIES

Water System:
As informed by the auditee, the source of Raw water is from Telangana Industrial Development
Corporation, which is collected in an underground tank. The Raw water is treated with Chlorine and
Alum in the UG storage tank. From this water is passed through a sand filter with aid of a hydro
pneumatic pump. The filtered water is simultaneously fed into Water system-I (which caters to Line-I
& Line-III) and Water system-II (which caters to Line-II & Line-IV).
Purified water system: As explained during the audit, the filtered water from the sand filter is fed into
the activated charcoal filter. The filtered water is collected in a 500 L SS tank for further treatment.
The filtered water is then pumped through a UV sanitizer into the Demineralisation (DM) unit
comprising of cation and anion exchanger and through the mixed bed. The conductivity of the DM
water is maintained below 1.3 S. The output of DM unit water is 3KL/ hour. Water generated from
the DM unit is monitored for Conductivity and pH. As informed by the auditee, in case, if the
conductivity exceeds the limit, the DM plant automatically goes for regeneration. The DM water is
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then passed through a UV sanitizer and a 5 filter into the ultra-filtration unit. The permeate of the
ultrafiltration plant is collected in a sanitary storage tank of 3KL, fabricated with SS 316L. The ultra-
filtration unit comprises a single pass-through a system consisting of a 3 membranes of polyether
sulphone, which are held in independent sanitary housings.
The purified water is distributed using a sanitary distribution loop at ambient temperature. The
ultraviolet sanitation system is provided at the start of the distribution loop & Immediately after the
sanitary distribution pump. The return of the loop is provided with a Back Pressure Regulating Valve
and a spray ball with 360° coverage. The return water flow velocity at the return of the loop is
maintained at > 1.2m/sec. The distribution system is provided with an inline TOC meter, pH sensors,
Flow meter, and Conductivity. The purified water system including storage and distribution lines are
sanitized using 5% Hydrogen Peroxide (H2O2) once in every 15 days.
As a part review, examined the UV lamp maintenance record and determined that the UV lamp has
been replaced on 3rd Jul 2021. The record also cumulates the lamp burning hours. Upon completion of

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stated max lamp burning hours, the lamp is replaced and documented accordingly as per procedure
QA/066.
As informed by the auditee, the manufacturer, installed capacity of PW systems are as follows:
Name of PW system manufacturer Installed capacity Catering/Distribution to lines
Aquatech Engineering services 1000 ltrs/hour Line-IV
Wipro water limited 3000 ltrs/hour Line-II
Water for Injection: As explained during the audit, the input to the WFI system is purified water
generated by an ultrafiltration system. The purified water is stored in the 3KL tank and is supplied to
Multi-column distillation still. The multicolumn distillation produces WFI at a rate of 500L/hour. The
WFI is collected in a 1KL SS316L tank.
The WFI is distributed using a sanitary distribution loop at a temperature more than 70°C. Flow in the
recirculation line is maintained using a Back Pressure Regulating Valve installed before the spray ball
on the top of the storage tank. The return of the loop is provided with instrumentation such as inline
TOC meter, pH sensors, Flowmeter, Conductivity, and Temp sensors. The return water flow velocity
at the return of the loop is maintained at > 1.2m/sec. In addition, the WFI storage tank is equipped with
a hydrophobic vent filter of 0.2m in a housing provided with heat tracing.
Based on the review of the layout presented, understood that 06 user points are available in Line III
from WFI-1 and the areas catering are as follows.
----------------------------Distribution to Line III from WFI system -1-------------------------
Unit preparation Vessel Washing Solution Filtration Tray
Area Wash Area Preparation Area washing
Area Area Area
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As a part review, examined the sanitization record dated 19th Jul 2021 and found it to follow applicable
procedural requirements. As informed by the auditee, the manufacturer, installed capacity of WFI
systems are as follows:
Name of WFI system manufacturer Installed capacity Catering/Distribution to lines
Ludwig control system 1000 ltrs/hour Line -I & Line III
Aquatech Engineering services 1000 ltrs/hour Line-IV
Wipro water limited 1500 ltrs/hour Line-II
Purified water system-II. As explained during the audit, PW-II receives chlorine-treated water from
the sand filter of an existing water treatment system. The chlorine-treated water is first stored in the
tank and is then pumped to the Sodium Metabisulfite (Na2S2O5) dosing unit, which removes free Cl-
ions in the feed water. This unit consists of an ORP meter, which helps to control the free chlorine
level in the line based on the set ORP value.

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Dechlorinated water is then pumped through the O3 dosing unit and is further stored in a tank made up
of SS316L. The O3 treated water is then pumped through a UV exposure unit, which removes the
Ozone (O3) from water. The water is then passed through the MGF unit that removes suspended matters
from feed water. This unit is provided with pressure gauges to monitor the pressure drop across the
bed.
The filtered water is then passed through an Ultrafiltration unit consisting of housing with a UF
membrane and pumps. The permeate of the Ultrafiltration unit is collected in a storage tank made up
of SS316 L. The Ultrafiltration unit is sanitized using Hydrogen Peroxide (H2O2). The permeate of the
Ultrafiltration unit is pumped through a Demineralisation plant comprising of strong Acidic Cation
Exchanger (SAC), strong Base Anion Exchanger(SBA) and Polishing unit. The water generated from
DM unit is monitored for conductivity and pH. In case if conductivity exceeds the set limit the plant
automatically goes for regeneration.
DM water is then passed through a UV sanitizer and a 5m filter and finally into the RO unit, which
generates Purified water. The RO unit comprises a single pass-through system consisting of 7
membranes, which are held in sanitary housings. The Unit has an online conductivity meter and pH
meter, which monitors the quality of purified water. The purified water is recirculated through the RO
unit in case of a high level in the PW storage tank. The RO unit is sanitized by Hot water.
The purified water generated by the RO unit is stored in a 3KL storage tank, made up of SS316L. The
Purified water is distributed to user points using a sanitary distribution loop at ambient temperature.
The UV sanitizer is provided in the distribution loop. As informed by the auditee, all the distribution
piping meets the specified limit of a dead leg. The return of the recirculation loop passes through a
TOC meter, Conductivity, pH meter, and flow meter. If the purified water fails for any of the above set
limits, a valve in the return loop opens to dump the water into the drain. The return line of the PW
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storage tank is provided with a spray ball with 360 coverage. The return water flow velocity at the
return of the loop is maintained at > 1.2m/sec.
Water for Injection-II. As explained during the audit, the input for WFI is the PW generated by the
RO unit of the existing PW system. The purified water is stored in a 3KL tank is supplied to the Multi-
column Distillation still. The multi-column distillation produces WFI at a rate of 500L/hour. The WFI
generated from multicolumn distillation is supplied to the existing WFI storage tank of capacity 1.5KL
made up of SS316L.
The WFI is distributed using a sanitary distribution loop at a temperature of more than 70°C. The return
of the loop is provided with instrumentation such as TOC meter, Conductivity sensor, Flow meter, and
Temperature sensor. The return water flow velocity at the return of the loop is maintained at >1.2m/sec.
In addition to WFI storage tank is equipped with a hydrophobic vent filter of 0.2m in a housing
provided with heat tracing.

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The entire system is designed to produce and distribute WFI meeting chemical specifications laid down
in IP/BP/USP & Ph. Eur monograph with conductivity NMT 1.3S/cm and TOC NMT 500ppb.
The system is monitored and controlled for TOC, Conductivity, Flow, and Temperature through a
SCADA based PLC which is equipped with alarms and fail-safe features to ensure that the water is
meeting the laid down specification. The WFI system is sanitized every fortnight using steam
sanitization. All the wetted parts are made up of SS316L. All the gaskets are made of inert materials
like Silicone/Viton.
Pure steam Generation system is designed to produce pure steam which (upon condensate) complies
with the USP/IP/BP monographs of Water for Injection. As informed by the auditee, the Pure steam
generator is integrated with the Vial II water system area on the second floor. The system consists of
Tubular steel structures with a pure steam generation column, a series of vertical preheater, electrical
panel board. The system is operated completely through a PLC system which ensures efficient working
of the plant under favourable conditions. The wetted parts used are SS316 L. Pure steam Generator
works on Falling Film Evaporator principle, employing a high temperature which assures a supply of
high purity pyrogen-free sterile steam. The PSG is designed to produce 500kg/hour of pure steam using
purified water and plant steam at 6Kg/cm2. The unit is designed to remove microbial contamination
by three stages of separation. PSG has a single effect unit comprise of an innermost evaporator (Shell
and Tube heat exchanger) an immediate separator and an outer column. The source of energy for this
effect is Boiler steam.
A Specially designed distribution plate ensures the water falls down the tube as a ‘Thin film’, which is
heated with plant steam and causing it to instant flash evaporation. This flash evaporation helps the
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steam to leave behind the heavier particles or droplets (1st stage of separation). This transformation
from water to steam significantly increases the velocity as it approaches the bottom of the column with
high pressure.
This vapor as it moves outside the tubes is forced to change its direction to 180. This directional change
induces the separation of large water droplets (2nd stage separation) which fall into the bottom of the
column, where they are collected with excess feed water that has not evaporated.
As the steam moves upwards, the spirals provided on the shell of the evaporator force the steam to
move in a circular part. This results in a centrifugal force for the remaining microscopic droplets and
impurities including the Endotoxin to the outer surface, which then get blown through the windows
provided on the separator (3rd stage separation). The outcome of this stage is high pressure, pure,
pyrogen-free sterile steam.
Compressed Air system:

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As informed by the auditee, the equipment consists of a compressor, motor, motor starter, inlet filter,
aftercooler, air receiver, air dryer, control systems and instrumentation.
The compressor module consists of a 30 HP motor. The motor and V belts cover with wire meshed
guard to the rotating sheaves and to prevent persons or objects from coming in contact with these
moving parts of the compressor. The inlet filter is provided at the suction side to prevent harmful
particles from entering the compressor cylinder and to minimize noise. The Aftercooler is installed to
cool to compressed air after the final compression stage with a capacity of 110 cfm.
The compressed air system also consists of a receiver designed as per ASME code with inspection
opening, safety valve, and pressure gauge. The receiver efficiently controls the load cycle and
minimizes air piping pulsation and has a capacity of 1m3.
Reviewed the procedure EG/209 for ‘Starting and Stopping of Air dryer’. Reviewed the daily
monitoring record vide format F/EG/209/01/01, dated 23rd Jul 2021, and found to be following
procedural requirements.
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SECTION IV-QMS SET UP & DOCUMENTATION REVIEW

The following section is based on the documentation review. This also includes the document requested
during the site tour for additional examination and/or scrutiny.
Site Master File (SMF):
The SMF presented during the audit was SMF/G2/32, which was effective from 14th Jun 2021. The
SMF is adequate in accordance as per PIC/S requirements & other requisites of EU GMP Vol.4 The
appendix of SMF includes;- Copy of Valid manufacturing authorization, List of Products
manufactured, Copy of Valid GMP certificate, List of Contract agencies, Organization chart, Layout
plan, General flow of process, Layout & PID of Water systems, List of Major equipment and
instruments in Manufacturing and Quality Control, Schematic diagram of AHU
Validation Master Plan (VMP):
VMP presented during the audit was vide number VMP/2021/01, which was effective from 2nd Jan
2021. Based on interaction with the auditee, it was understood that VMP serves as a guiding document
for initiating qualification and validation activities and to ensure that manufacturing and its related
activities are in a validated state to meet the cGMP requirements. Head/designee of site QA approves
Validation documents. The overall validation and qualification activities are coordinated by a team
comprising from various functions such as QA, QC, Production, Engineering, R&D. If the Validation
/Qualification document of the manufacturer complies with the requirements of ABC labs, the same
document is accepted through a sign-off . The scope of VMP applies to Equipment, Processes, Systems,
Methods, Utilities. A requalification strategy is also defined for each type of validation/qualification.
Re-qualification of equipment is performed on 5 yearly basis.
Documentation:
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Documents related to GMP are prepared by the user department and approved by QA and are handled
as per sop QA/008 ‘Handling of Master documents. Based on documents presented during audit and
interaction with the auditees, it was understood that all documents are prepared, checked, approved,
authorized, issued, retrieved, and archived as per laid down procedure. The documentation comprises
specifications of starting materials, in-process materials, finished products, Master formula card,
Master Packing card, Batch Manufacturing record, and Batch Packing record.
Batch documents are archived as per systemic procedure QA/027. As informed by the auditee, adequate
precautions are taken for their security and to protect them against any infestations and adverse
conditions. Reviewed the SOP and found that the procedure indicates the minimum retention period of
various GMP documents. Specifically, all the batch-related documents (BMR; BPR; TDS) are archived
for a period 1 year after the expiry of a drug product. Other GMP documents such as MFR, SMF, VMP,
Qualification & Validation documents are archived as perpetual. During facility, tour visited the
Document Archival area and Observed all documents are archived on-site under lock & key. The

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document archival area is found to be meeting the necessary prerequisites. All paper-based GMP
documents is stored in Compactor racks, which are labeled and well maintained.
Product Quality Review (PQR):
As informed by the auditee, understood that the frequency for preparing PQR is staggered. Reviewed
the sop and found to be adequate in meeting the applicable regulatory requirements such as to
incorporate the details of; -Supply chain traceability, manufacturing data including CPP, Trend
analysis, Validation summary covering the Process & Cleaning; Equipment qualifications and
requalification, Stability studies, Observation of retained samples, Product-specific change requests,

deviations, incidents, CAPAs, OOS, review on quality trend, Market complaints, Return goods and
recalls with description, previous year recommendations along with section-wise conclusions.
Reviewed PQR report of Tranexamic acid Injection 100mg/ml (Vide # APQR/TCO/2020, approved on
20 Sep 2020) and no discrepancy was observed. The trend for all CQA is found to be satisfactory. Since
the other drug products (in the scope of audit) are not commercially manufactured (and marketed) no
PQR reports are available for the same.
Process validation:
Process validations are handled as per systemic procedures. Reviewed process validation protocol (vide
# PVP/TCO/G2/M/01) of Tranexamic Acid Injection. The review determined that the protocol is
adequate complying to the minimum requirements. The rationale for stratified sampling is included as
part of the protocol. Also reviewed the report (vide # PVR/TCO/G2/M/01) . The batches for validation
are TCO1KA2; TCO2KA2; TCO3KA2. Representative samples have been collected from specified
strata as indicated in the protocol. Established CPP’s and Known CMA’s have been monitored as part
of PV activity and have been compiled in a report. The bioburden monitored, integrity check before
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filtration, and Integrity check after filtration is found to be adequate. Also reviewed the filling
validation report, which was found to be adequate.
Continuous Process Verification As indicated in non-conformity -3 it was understood, no systemic
process and/or approved procedure is available to evaluate the process performance Indicated the
regulatory requirements in this caption to the auditee.
Aseptic process validation is handled through pre-approved protocols. Reviewed the periodic media
fill protocol (vide # GSP/Q/19/049, dated 29 Dec 2020). The study design included; - Representative
number, type, and complexity of normal/routine interventions (at infeed zone, infeed star wheel, filing
zone, Outfeed star wheel, Environmental monitoring), Corrective/Non-routine interventions (such as
Filling machine breakdown, Change of syringe needles during filing activity by opening machine filing
door, Adjustment of feed star wheel by opening filing machine door, Tea break, Dinner break, Operator
changes during shift change over ). Soybean hiveg medium, sterile Powder (3.%w/v) was used. The
fill volume was 1.0ml. GPT report was available for the media used for the study. All the filled units
(21864 ampoules ) are incubated. The initial incubation conditions are 20–25°C for 7 days, followed
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by 30–35°C for 7 days. NO growth was observed. Verified the reconciliation data against the number
of vials incubated and found it to be accurate.
Cleaning validation:
Based on the documents presented for review, it was understood that MAR values are derived based
on PDE values. Reviewed the CV matrix vide # CVM/Line-III/01 and determined that PDE values are
included for deriving the limit of residue (contaminant) in the next subsequent product to be
manufactured. Additionally, substantiated the statements provided by the auditee (ABC), on 18 Aug
2020 to the client (XYZ) and found that the response provided is valid. PDE values for molecules
(related to the products in the scope of audit) are presented for review and along with related reference
toxicological monographs and Study data. PDE values are determined by an Accredited toxicologists
(for which a technical agreement is in place). Reviewed the Cleaning validation plan and determined
that, if a product is worst case (i.e.) Lowest value arrived when using with PDE , cleaning validation is
performed for 3 consecutive batches and test results are evaluated. In other cases, (i.e.) if the product
is not being a worst-case, then cleaning verification is performed for 1 batch and testing the samples.
Reviewed cleaning verification protocol (vide # CVP/ 01/00) of Tranexamic Acid Injection 1mg/ml
and found that protocol is adequate complying to the minimum requirements. The approach is mainly
through the CIP cycle. The protocol also warrants the need for Training for operators. Also reviewed
the report (vide # CVR/01/00), which has been compiled after successful completion of cleaning cycle.
The batch considered was TCO1KA2. Overall, the cleaning validation approach was found to be
satisfactory.
Analytical Method validation :
As informed by the auditee, it was understood that analytical method validation is performed at the
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R&D center. All analytical methods are transferred in accordance with procedure QC/212. Reviewed
the method transfer reports of Tranexamic Acid Injection vide # GSR/QC/17/00 for Assay, Related
Substances and found to be adequate. Also reviewed the cleaning validation report
(AMVR/IG2/19/012) of Tranexamic Acid Injection and found that parameters considered for method
validation are adequate and appropriate. Specifically, the accuracy at the LOQ level ( by spiking the
appropriate amount of target on the specific MoC) in the receiving site was evaluated as part of method
validation.
Deviations:
Any departures from the approved standard operating procedures and/or protocols are handled through
the corporate procedure. Reviewed the procedure and found it to be adequate. As part of governing
procedure, an assessment is performed to assess the potential impact on product quality and/or patient
safety and/or product identity. Based on outcomes of such assessment, the deviations are categorized
either as ‘Minor’ Major & Critical. Reviewed the following deviations.
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Deviation.# Batch Deviation description Root cause identified

number(s)
DEV/G2 Tranexamic During BMR review by IPQA Due to malfunctioning of
/20/135 Acid personnel, it was observed that NVPC probe
TCO 1EB2 multiple NVPC excursions were
observed during the filing process.
DEV/G2 Tranexamic On 20/07/2020 during the audit trail The system has rebooted
/20/203 Acid review of automatic sticker labeling without cleaning shutting
TCO2AB2; machine with Equipment ID ;P/580, down first. This error could be
TCO10LA2 it was observed by QA personnel caused if the system stopped
that the data, were not available in responding, crashed or lost
the audit report, while the entries of power unexpectedly.
same were recorded in recording and
maintenance of equipment logbook.
and determined that, hypothesis approach followed to identify the root cause, followed by proposed
CAPA was found to be appropriate and satisfactory. Also, based on the data presented it was
understood that total of 308 deviations have been logged during the year 2020.
Change Control :
All change proposals within the GMP environment are handled as per the approved corporate
procedure. Reviewed the procedure and found it to be adequate . Also determined that a Risk
assessment is carried out to scenarios as necessitated and/or as warranted by QA. The scope of
procedure applies to New additions and for making any change/modifications in the approved System,
Process, Procedure, Facility, and documents. As requested by client, a random sample of change
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notifications triggered due to artwork changes from XYZ were taken for review.
Change notification Description of change Initiation Closed on
# date
CCF/QC/P/G2/312/20 To implement revised packing material 19th May 17th Jun
specification for the product Tranexamic acid 2020 2020
100mg/ml, XYZ-PT, LBL Tranexamic acid
100mg/ml, XYZ-PT, SP-5ml having PMS no.:
PMS/P2PT00002, rev. no.: 01
CCF/QC/P/G2/345/20 To implement revised PM specification for the 29th May 31th Aug
product Tranexamic acid 100mg/ml XYX(i) 2020 2020
Carton Tranexamic 100mg/ml XYZ-PT 10 x 10
ml having PMS no.: PMS/P2PT00007, rev. no.:
00 (ii) Carton Tranexamic 100mg/ml XYZ-PT 10

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Change notification Description of change Initiation Closed on

# date
x 5ml having PMS no.: PMS/P2PT00008, rev. 00
(iii) Leaflet Tranexamic 100mg/ml XYZ -PT
having PMS no.: PMS/P2PT00009, rev. 00
CCF/QC/P/G2/683/20 To implement revised PM specification for 12th Oct 15th Oct
product Tranexamic acid XYX 0.5g/5ml 2020 2020
injection, leaflet Tranexamic 0.5g/5 ml XYZ
France having PMS NO. PMS/P2FR00009

REV.00
Concerning to products in scope of the audit, only Tranexamic Acid Injection, is commercialized and
there were NO change initiated due to revision of Specification, post commercialization. Hence
following change notification , which was initiated to respond to regulatory authority was sampled for
review.
Change notification Description of change Initiating Closed
# date on
CCF/PR/P/G2/188/20 To revise BMRs for the product Brinzolamide 2nd Jun 21st
ophthalmic suspension USP 1% Prefix-BCB, 2020 Aug
batch size-100L, BMR Nos- 2020
BMR/BCB/E08/G2/0.1M (Bulk),
Upon re-examination, in specific instances, extensions (for implementing the change) have been
requested by the change initiator/process owner with rationale and same have been authorized by QA.
All the identified action items for the above change notifications, have been implemented successfully.
Based on the data presented, it was understood that total of 1594 change notifications have been logged
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during the year 2020. Unless justified, all change notifications are completed within the stipulated
timelines as indicated in governing procedure. Based on interaction with the auditee, it was further
understood that until 14 Dec 2020, all change notifications are initiated manually (i.e.) through Paper-
based approach. Thereafter change notifications are handled through TRACKWISE. Overall, the
management of changes was found to be thorough and no anomalies were observed.
CAPA:
All the activities related to CAPA (such as Initiation, Tracking, closure, etc) are handled as per
corporate procedure. Reviewed the SOP and found it to be adequate. As requested by client (XYZ
healthcare), CAPA’s triggered as part of the previous audit (dated 7th Jul 2018 for Plant II) by TAKEDA
Pharmaceuticals ltd, was taken to consideration. The audit report (vide # FPS_005_2018) dated 06
Aug 2018, compiled by the audit team (Mr. Nilesh Patel & Mr. Rakesh Patidar) indicates total of 27
observations, specific to plant II. Substantiated the evidence of CAPA closures, for each observation
and determined that all the proposed CAPA’s are successfully implemented as of date. Understood for
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those action items 9 which are tracked through CAPA notification numbers CAPA/G2/19/004 and
CAPA/G2/19/037, which has been closed on 8th Feb 2020 and 20 Mar 2020 respectively. Unless
otherwise justified and granted with extension, there is no overdue CAPA at this point. Overall, the
management of the CAPA was found to be satisfactory.
Employee Training:
Based on interaction with the auditee, it was understood that any individual upon joining, should
mandatorily undertake the induction training program, which comprises Employee safety, cGMP,
GDP, and topics related to applicable areas, where he/she will be supposed to work. After successful
completion of the Induction training program, Job responsibilities are agreed upon by the employee,
Head/designee of the department, and finally approved by QA. All the training courses are
administered manually as per the approved corporate procedure. In addition to the induction program,
other types of training such as; - On-job training, Unscheduled trainings during procedural revision,
etc. are imparted as & when necessitated to the applicable group of employees. Additionally, there is
also a GMP refresher training on yearly basis for each employee. Training needs for the individual
employee (who are ‘on roll’) are identified by the Head/designee of the department, based on which a
staggering yearly training plan is framed out. The yearly training plan includes mandatory topics such
as;- cGMP, Regulatory updates/ existing landscapes in regulatory setup, Technological improvements
(if any) in the relevant area work area. The identified employees are trained by the certified trainers, as
applicable. As verified during the audit, the training records for an employee (as & when required) are
downloaded from the system and are up to date. Verified the job responsibilities of employee Mr.
Akshay Khot (Emp code 34531) against the training completion records. All the sop’s relating to
assigned Job responsibilities have been completed. Overall, the Training management system was
found to be satisfactory.
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Internal audit/ Self-inspection:
Self-inspection is planned as per systemic procedure QS/062 and performed by qualified internal
auditors. Reviewed the sop and determined that self-inspection is carried out bi-annually & annual
schedule for self-inspection (of the upcoming year) needs to be prepared within the December of the
current year. However, for the calendar year (2021), the schedule was approved on 13th Jan 2021. No
explanation for the delay was cited in the schedule. Refer Nonconformity 4.1
Upon review of the procedure determined that a trainee auditor needs to complete at least 3 internal
audits under the guidance of the Lead auditor. Reviewed the Auditor evaluation record of the Trainee
auditor (Mr.Ganesh Shinde) against the format (vide F/QS/062/04/01).
In accordance with clause 6.22, during the evaluation process of the trainee auditor, the lead auditor
is required to assess the observations made by the trainee auditor. However, there is no documentary
evidence to substantiate the evaluation made by the Lead auditor for those observations cited by trainee
auditor. Refer Non-conformity 4.2
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_____________________________________________________________________________________________________________________________________________________________________________________________________________________
Out of specification (OOS):

The Out of specifications observed during testing is handled as per the corporate procedure. Based on
interaction with the auditees and with aid of procedure, understood the investigation flow. Specifically,
there is the involvement of Analytical QA, starting from Hypothesis testing, Retesting, etc. The
approach for each phase of investigation was found to be adequate. Reviewed the following OOS
notifications –
OOS.# Product and Batch OOS description Root cause identified
number(s)
OOS/G2 Tranexamic Acid Ph.Eur An OOS result was observed for assay Instrument error:
/19/054 B.No. X1903019M (on dried basis) test by auto titrator intermittent air bubble
AR.No: RM/0075/19 Results observed= 101.9 %m/m in the tubings.
Specification Limit= Between 99.0%
m/m and 101.0% m/m
OOS/G2 Lacosamide Injection An OOS result was observed during Pressure fluctuation
/19/037 10mg/ml stability evaluation (12M; Condition caused due to the
Fill volume 20 ml 25°C/60%RH; Inverted orientation) minute unseen air
Batch .No.LFA3C82 for any other impurity during the bubbles
Related substances test. Results
observed= 14.51 % at RRT 0.14
Specification Limit for any other
impurity= NMT 0.20%
and determined that the investigation approach followed to determine the root cause, followed by
retesting & invalidating the initial observed results was found to be appropriate.
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Understood that OOS and OOT summary reports are prepared every quarter-wise. Upon review of
record, inferred that no OOT notifications were logged during the year 2020.
Reviewed the systemic procedure for OOT and determined that, the investigation approach is identical
in a similar manner of handling OOS. The systemic procedure has an approach of recognizing the OOT
based on certain proportions to specification limits/window. Overall, the management of OOS & OOT
was found to be satisfactory.
Equipment Qualification:
Equipment qualification: Based on discussion with the auditee, it was understood that any new
equipment received at the site is required to be qualified. Equipments is re-qualified at specific intervals
(5 years in general). Factory Acceptance Testing is performed for all major equipment at the original
equipment manufacturer premises, before receiving at the manufacturing site. Commissioning of
equipment is as per checklist, which is customized for each type of equipment. After commissioning,
Qualification is performed in accordance with approved protocol. Only after successful completion of
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_____________________________________________________________________________________________________________________________________________________________________________________________________________________
PQ activities, followed by QA review and approval, the equipment is assigned for routine usage. The
numbering nomenclature for protocol issuance and report generation is indicated in the systemic
procedure.
Reviewed the AHU qualification protocol cum report vide number for AHU-005 catering to filling area
of line-III and found that parameters (such as Air velocity, Air changes per hour, Filter Integrity, etc)
be adequate & well within pre-determined limits. Also reviewed the validity of particle counter (Serial
# 196617) which was valid up to 14th Apr 2022
Reviewed Re-Qualification of filling line-IV vide number RVP/E/273/07, dated 7th May 2021, and
found to be adequate. Reviewed periodic Requalification of Pure steam generator system (CES-077-
02). Following parameters: - Superheat test, Dryness test, Non -condensable gas test, are evaluated.
Report vide PRQR /CEES077 /001-00 has been compiled and approved on 23 Nov 2020.
Preventive Maintenance (PM):
Reviewed the preventive maintenance schedule for the year 2021, prepared by the Engineering
department and approved by QA. The schedule is found to be adequate and has a tolerance window.
As informed by the auditee, the activity is coordinated with production, considering the ongoing
activities. Upon completion of maintenance activity, the equipment history cards are updated
accordingly and relevant entries in the equipment usage log are updated. The activities include service
checks, repairs, modifications, replacements, etc.
The preventive maintenance performed by the engineering department for Vial filling & Stoppering
area, dtd 24th Jun 2021 was reviewed and found to be satisfactory. The preventive maintenance
includes;- Filter cleaning, Integrity testing, duct cleaning
Market Complaints:
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As informed by the auditee, any complaints received (at CQA or RA) related to quality are directed to
site QA for investigation and corrective actions. The site QA personnel initiates the assessment in
coordination with relevant functions to verify the validity of the complaint and to identify root causes.
The details of the complaint are logged (in Trackwise) to enable the QA to follow up until the complaint
is suitably addressed. The investigation is performed jointly by QA & Manufacturing team. The
investigation approach also entails steps to recognize (suspect) counterfeit medicinal products.
Complaints that are critical in nature are taken extra care. Based on the criticality of complaints
subsequent actions such as Field alerts, Quality alert notifications are initiated. The QA department is
responsible for classifying the complaints (either as minor, major and critical) investigating and
ensuring the implementation of CAPA for complaints. The investigation report is approved by QA.
The trends of complaints are analyzed every quarterly to identify areas to be focused on for necessary
process improvements.
Recall:

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Depending on the nature of complaints, a Product recall is planned. Reviewed the SOP and determined
that recalls are classified based on the severity of complaint substantiated with information &
investigation data available.
Class I. Recall situations arise when there is a reasonable probability that use of or exposure of a
defective product is life-threatening or could cause serious risk to health or death.
Class II. Recall situations arise when there is a reasonable probability that use of or exposure of a
defective product could cause temporary health problems but is not meeting the threshold as class I.
Class III. Recall situations arise when there is a reasonable probability that use of or exposure of a
defective product is neither class I or class II and does not pose a significant hazard to health, but
withdrawal is initiated for other reasons.
The sop dictates the details related to communication channels to be used, the access to distribution
records, the names, and addresses of concerned persons involved in the distribution chain, and
effectiveness recall. Head -CQA is designated as recall coordinator and is responsible for execution
and coordination for recalls. The SOP also mentions the need for Mock recall to verify the effectiveness
of existing controls at least once a year. Since there are NO recalls initiated on a voluntary basis by
ABC laboratories limited or ordered by any regulatory agency/authorities, the outcomes of mock recall
were requested during the audit. It was understood that a mock drill for Recall was initiated for the
product Olopatadine HCl. The overall recall process at the supply chain level has been completed much
earlier as mentioned in the SOP. The outcomes of mock recall were following stated requirements of
the approved procedure.
The finished goods returned from the market are quarantined separately and where appropriate & as
suggested by QA are evaluated by QC to recognize any possible problems with the batch. All those
returned goods are kept separately. Appropriate CAPA is initiated as per the governing procedure.
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Overall, the management of complaints and the recall process was found to be adequate. As informed
by the auditee, the recalled goods are collected at the central warehouse, segregated and clearly labelled
as ‘RECALLED’ and destroyed, for which destruction records are maintained.
Management of suppliers:
Supplier Qualification is performed by QA and /or Development QA team with support from Supply
chain management. As informed by the auditee, for new suppliers (proposed), generally the
qualification process is initiated through a Set of vendor questionnaires, Evaluation of questionnaires,
and other documents (such as TSE/BSE declarations, Elemental impurities assessment, etc) provided
by the supplier/vendor. An onsite audit is planned based on compliance history data, outcomes of the
questionnaire, results of evaluation samples, etc.
In the case of API, the requalification frequency is based on audit outcomes (i.e.) category and the
number of findings. The summary is as follows

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Audit Outcomes Re-qualification Frequency-API Risk

Rating
Critical findings Immediate (as soon as possible within 2 years) I
> 6 Major findings 24 months II
< 6 Major findings 30 months III
No critical or major findings 36 months IV
In the case of the Excipients the requirement for conducting the Manufacturer, audit is concluded based
on risk assessment. The need for conducting the manufacturing audit is concluded based on the risk
rating value and Classification. If a risk is identified as ‘low’ then the excipient site is not audited.
The Risk assessment is conducted every 3 years
Assessment Outcomes Cumulative score for excipient manufacturer Risk level
Critical rating 94 to 124 High
Moderate rating 63 to 93 Medium
Negligible rating 31 to 62 Low
In the case of Medium and High risk, the audit is conducted, and the risk rating is given based on audit
output. In the case of Excipients, the requalification frequency is based on audit outcomes (i.e.) category
and the number of findings. The summary is as follows
Audit Outcomes Re-qualification Frequency-Excipients Risk
Rating
Critical findings Immediate (as soon as feasible ) I
> 6 Major findings 30 months II
< 6 Major findings 36 months III
No critical or major findings 48 months IV
For existing suppliers, performance is verified for raw material supplied. Controls are in place to ensure
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the materials received are compliant concerning TSE/BSE requirements, Counterfeit/falsified active
pharmaceutical ingredients or excipients are identified. Upon qualification or requalification, Quality
Technical agreements are in place with such suppliers/vendors, wherein responsibilities are defined in
inline as Marketing Authorization requirements. Upon review of vendor qualification documents, the
following discrepancies as were noted.
 Supplier assessment was not performed for any of the suppliers as per the 5.10.2 section of the
standard procedure (QS/013) which suggest the assessment be performed based on the
complaint, OOS, deliver, audit outcomes, etc. However, it was noted that the audit outcome was
only considered as part of the evaluation. Refer Non-conformity 5.1
 Despite, the Supply chain traceability of the Tranexamic Acid was available in the document
number SC/20/G2/01, the document lacks the information concerning the details of a different
modes of transport along with logistic points during the entire transportation process. Refer
Non-conformity 5.3
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Based on supplier qualification documents presented during the audit, it was confirmed that all the
suppliers related to products under the scope of the audit have been audited and the re-qualification
dates are as follows.
Name of the Name of the manufacturer and Name of Date Audited Requali
Manufacture address the API of last by fication
r audit due
date
Hunan Address: No. 16, Dongyan Road, Tranexamic 17th Mr. 17th Dec
Donting Deshan, Changde city, Hunan Acid Dec Prashant 2021

Pharmaceutic Province, PRC-PC415001. 2018 Vernekar
al Co Ltd
Chirogate Address: No. 41, lane 298, Gong 2nd Bimatoprost 15th Mr. 15th
International rd and no. 22, Alley 39, Wulin May Prashant May
Inc Village, Longtan township, Taoyuan 2019 Vernekar 2022
Taiwan 32559.
Polpharma Pharmaceutical works Baclofen 18th Dina 18th
SA Polpharma Address: 19 Pelplinska Sep Ghali Sep
street, 83-200 starogard Gdanski 2018 Damian 2021
Poland Siepieto
wski
INDUS Address: R-96/98, TTC Industrial Lacosamide 16th & Mrs. 16th
remedies ltd Area, MIDC, Rabale Navi Mumbai 17th Aarti Feb
400701. Feb Gholba 2024
2021 Dr.
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Vivek
Jadhava
Note: As informed by the auditee, the project ‘URAPIDIL’ was dropped out.
Excipient Risk Assessment:
Reviewed Excipient Risk assessment of Citric Acid Anhydrous (F/QS/003/06/07). The assessment was
done by designated QA personnel. A discrepancy was observed in this report concering the conclusion
drawn based on assessment. The outcomes of assessment specifically the provisions for ‘Requirement
of Onsite audit and conclusion drawn has remained blank. Informed the same to the auditee. Refer
Nonconformity 5.2
Elemental Impurities:
Reviewed Elemental Impurities Risk Assessment of following finished drug products;

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Name of Assessment Assessment Conclusion in brief

drug date done by
product
Tranexamic 31 Aug 2018 Mr. The risk assessment data proves that the level of
Acid Mahantesh elemental impurities present in the drug product is
Injection Mali considerably below the control threshold. Presented data
confirm that the starting material, container closure
system, and manufacturing equipment facilities and
materials do not contribute significantly to the content

of elemental impurities in Tranexamic Acid Injection
BP. It is therefore concluded that no further controls on
elemental impurities are necessary.
Baclofen 7th Jun 2021 Ms. The screening of elemental impurities was performed,
2mg/ml Utkarsha the level of elemental impurities present in the drug
Intrathecal Sarang product is considerably below the control threshold. The
injection performed risk assessment demonstrates that the starting
material, manufacturing equipment, packing, and utilities
do not contribute significantly to the content of
elemental impurities in the product. Therefore, it is
concluded that no further control on elemental impurities
is necessary.
The assessment was in accordance with ICH Q3D guideline and found to be adequate.
Nitrosamine Impurities:
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Reviewed Nitrosamine Impurities assessment of Tranexamic Acid Injection dated 3rd Jun 2021. The
assessment was done by Mr. Amol Rajmane (QA), was in accordance with ICH M7 guidelines. The
assessments concluded control measures available at the site and vendor declaration about the
generation/testing of the Nitrosamine Impurity from API and excipient supplier /vendor /manufacturer
has been evaluated. The overall risk score criteria are applied, and risk is categorized as Medium. Based
on Medium risk the product testing is to be conducted as per CAPA No. PR. 14503.
Quality Technical Agreement:
As informed by the auditee, the scope of agreements covers any activities related to GMP/GDP, which
are outsourced. These also include contracts made to the supplier. All the QTA are approved by Head-
Quality Management. Reviewed agreement between ABC remedies ltd and CHOKSI labs (Indore)
dated 5th Jan 2021 and found to meet the applicable requirements. Additionally, a draft copy of the
Technical Agreement (QTA/56/01) was presented for review. The drafting is initiated to include other
products of XYZ Healthcare Limited and as part of continual improvement. Understood that Urapidil
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project has been dropped out. Accordingly, the product has been removed. Based on the information
provided by the auditee, it was understood following activities (within the scope of GMP/GLP) are
outsourced to external agencies through a technical agreement.
Details of activities Name of the agency Address of the agency
undertaken by the agency
Calibration of measuring AUTOCAL B-1, Bollaram Co-op Housing society,
instruments Bowrampet, Hyderabad
QA TECH Plot # L-134, Phase IIIB, Balanagar Industrial
Estate, Hyderabad
Testing related to ACME clean room ORAV guest house,
Enviornmental monitoring services #31, Balanagar Industrial Estate, Hyderabad
HVAC and non-viable
monitoring
Certain QC tests on Raw Choksi Laboratories 6/3, Manorama Ganj,
materials, Packing Ltd * Indore , Madhya Pradesh-452001
materials and Finished VIMTA labs Life sciences facility, #5, Genome Valley,
products. Shameerpet, Hyderabad-500078
Indus Analytical R 92-93, Ground Floor, TTC, MIDC,
Solutions Thane-Belapur Road, Mumbai 400701
Iindus- plant III L-32,33, 34, Sultanpur Indl Area, Hyderabad
SITEC Labs (P) ltd PEE-DEE Info tech, Plot #40, Gen 40,
TTC, MIDC,Mahape, Navi, Mumbai 400701
Sequent Labs Ltd 120 A&B, Baikampady Industrial Area,
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Mangalore
SGS Labs SGS Life sciences services, 2nd & 4th floor, TICEL
bio park, Taramani, Chennai-600013
Penetrability test for ALS Labs #65, Bommasandra Jigani link road, KIADB Indl
Rubber stoppers area, Bangalore
Sterilization (Gamma & Microtrol #14, Bommasandra Jigani link road, KIADB Indl
ETO type) for Raw Sterilization area, Bangalore
materials and Packing
materials
Certain QC tests on Bulk Megsan Labs Plot# 33, Sy.Nos, 123,124 & 142
testing and on Finished Kompally, Hyderabad
products
* Arsenic test (for 5ml & 10 ml ampoules)

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Release of Finished Product:

Based on interaction with the auditee, it was understood that, upon completion of manufacturing and
packing activities, a dedicated team of QA personnel, examines the executed BMR, executed BPR (as
per stated requirements of systemic procedure QA/071) for its adequacy and compliance against stated
manufacturing/packing requirements. Concurrently, the TDS of the finished products, are scrutinized
by the Analytical QA team for its accuracy and compliance against the approved specifications. The
review of batch records (BMR; BPR ;TDS) is substantiated through a checklist as per the applicable
procedure. If any deviations are recognized (either during Manufacturing and/or Packing and/or
Testing) as part of the review, a notification is immediately logged by the process owner, and the
deviations are investigated and appropriate CAPA is derived. Other observations (such as
documentation errors, etc) identified as part of the review are endorsed/ corrected accordingly as per
the recommended procedures. Upon closure of deviations related to batch & all other observations, the
Batch release certificate is endorsed by authorized QA personnel with the date. Based on the
information presented during the audit, only the following personnel are empowered to release a batch.
 Mr. S.Narsa Reddy-Sr.GM.QA
 Mr. Thushar Lotlikar , Sr.Manager-QA
 Mr. Pradeep Holkar, Sr.Manager-QA
Anti-Tampering initiatives:
As observed in packing lines, as a measure to recognize tampering, an ATD sticker is affixed on both
flaps of the carton. Also, as informed by the auditee & observed, the automatic packing lines can
incorporate serialization requirements as per EU Falsified Medicine Directives. The generated serial
numbers (including the pallet level aggregation) can be uploaded to 3PL and/or EU HUB platforms, to
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have a track and trace approach for each batch of the drug product.
Distribution system for Finished :
As explained during the audit, it was understood that, upon release, finished drug products are
transferred to the central warehouse, further moved towards the supply chain through C&F agents. As
informed by the auditee, records of distribution are maintained, which include the details of Name of
Product, Batch number, Expiry date, Quantity transferred. Stock transfer notes are raised for further
distribution links. All records are reconciled every month to recognize any discrepancies.
As informed by the auditee, the reefer container is selected depending upon recommended storage
condition of a drug product. Upon arrival, the reefer container is checked for cleanliness and the options
available for maintaining the recommended storage conditions during transit. The pallets (containing
shippers of Finished product) are loaded as per the invoice and the Weather guard (Tyvek) is provided
as a blanket to avoid the impact of harsh environmental conditions on the product during transport. The
pallet stacking is done as per the recommended procedure. Calibrated Data loggers are placed at

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appropriate places within the reefer container. Upon completing the necessary documentation, the
consignment is dispatched to the customer warehouse and/or company warehouse as per required
storage conditions. The logistics team ensures that the distribution channel will comply with all legal/
license and customs requirements of the respective national agencies and the shipment /delivery to the
customer is ensured as per the marketing authorization requirements.
Data integrity:
Based on the review of records and/or reports presented, it was recognized that the principles of data
integrity have adhered. During the audit, prime information such as Batch Manufacturing records
&Batch Packing records is re-examined for its reliability towards the ALCOA requirements and
presence of significant anomalies. Manual corrections (where necessitated) in records presented are
appropriately corrected and initialized with sign & date, along with specific reasons for such
corrections. It is verified that several revision processes have been implemented and are fully recorded
in the history of Master BMR & BPR, so that entire details of changes can be traced back. A systemic
procedure vide QA/010 to cover the scope of “Good Documentation Practices’
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SECTION V-AUDITOR’S PROFILE

 Profile of Lead Auditor
 Profile of Co-Auditor
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SECTION VI-AUDIT COMPLIANCE RESPONSE/ CAPA

As an outcome to audit observations, the site QA has submitted an Audit response dated 24th Aug 2021
The excerpt of the response are as follows.
Masked due to confidential reasons. However , the same is available in a tabulated

format against each non-conformity.
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SECTION VII-AUDIT CLOSURE STATEMENT
With caption to the onsite GMP audit of ABC laboratories Ltd performed by Pharmasol UK Limited on
the above specified date(s), the non-conformities noted, have been informed to the auditee through an
audit summary report on 11th Aug 2021.
As a response, the auditee has submitted a compliance response /CAPA on 24th Aug 2021. The response
indicated including corrections made, if any along with their proposed CAPA for each of the non-
conformities, have been peer reviewed and found it to be robust and satisfactory.
The compliance response is deemed to be adequate with respect to the indicated CAPA, however it will
be the responsibility of site to maintain and continue the GxP practices in routine. Unless otherwise
justified and extension is warranted, all the proposed CAPA should be implemented within their
stipulated timelines. The site has been informed to notify , in case of any change or alterations in the
proposed action deliverables.
Hence , therefore, we are concluding this audit.
 For Pharmasol- UK
T.Arun Prasad
Lead Auditor Co-Auditor
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Dated : 30th August 2021 Dated: 30th August 2021

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_____________________________________________________________________________________________________________________________________________________________________________________________________________________
SECTION VIII-NON-CONFLICT OF INTEREST DECLARATION
I/WE hereby declare that there is no conflict of interest with the auditee m/s. ABC laboratories ltd.
I/We have neither been employed with audited company nor associated with them through any form of
contracts in preceding 5 years.
There is no conflict of interest for financial or nor-financial means with the audited company.
As a gesture of gratitude, we have been provided with a taxi for commute from our residential area to
the manufacturing site on the day(s) of audit and lunch.
 For Pharmasol- UK
T.Arun Prasad
Lead Auditor Co-Auditor
Dated: 30th August 2021 Dated: 30th August 2021
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APPENDIX -A-PERSONNEL ORGANIZATION CHART

Masked due to confidential reasons.. The same is available in actual report
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_____________________________________________________________________________________________________________________________________________________________________________________________________________________
APPENDIX B-OVERVIEW OF SITE LAYOUT

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APPENDIX C-SITE ACCREDITATIONS

Results from Eudra GMP database

> > END OF REPORT < <
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Repo rt pro vide d ex cl us ive ly t o Clien t t hrou gh ND A HC- 02 -108 2,dt d 2 3 Ju l 2 1; NOT TO BE T RAN SMITT ED FURT H ER

NAME OF THE AUDITEE ABC Laboratories Pvt Ltd

Type of products Finished Dosage forms: Sterile Injectables

AUDITING FIRM PHARMASOL UK Ltd.

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AUDIT CLIENT: XYZ Healthcare Limited

>> F o r a n y q u e r i e s / c l a r i f i c a t i o n s  i n f o @ p h a r m a s o l . c o m m e n t i o n i n g t he d o cu m e n t # < <

AUDITEE PARTICIPATIONS ............................................................................................................................... 3

EXECUTIVE SUMMARY ...................................................................................................................................... 6

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>> F o r a n y q u e r i e s / c l a r i f i c a t i o n s  i n f o @ p h a r m a s o l . c o m m e n t i o n i n g t he d o cu m e n t # < <

Doc # 1 30 60 8 Iss ued on 30 08 21

>> F o r a n y q u e r i e s / c l a r i f i c a t i o n s  i n f o @ p h a r m a s o l . c o m m e n t i o n i n g t he d o cu m e n t # < <

 Mr. Kalrav Patel, Sr.Manager-Warehouse

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UK MHRA Jul 2019 Approved

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>> F o r a n y q u e r i e s / c l a r i f i c a t i o n s  i n f o @ p h a r m a s o l . c o m m e n t i o n i n g t he d o cu m e n t # < <

SECTION II-EXECUTIVE SUMMARY AND AUDIT FINDINGS

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Doc # 1 30 60 8 Iss ued on 30 08 21

>> F o r a n y q u e r i e s / c l a r i f i c a t i o n s  i n f o @ p h a r m a s o l . c o m m e n t i o n i n g t he d o cu m e n t # < <

Sr.# Details of the non-conformities Ref. clause and expectations Category

used in the system.

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>> F o r a n y q u e r i e s / c l a r i f i c a t i o n s  i n f o @ p h a r m a s o l . c o m m e n t i o n i n g t he d o cu m e n t # < <

Sr.# Details of the non-conformities Ref. clause and expectations Category

continued capability of processes and

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>> F o r a n y q u e r i e s / c l a r i f i c a t i o n s  i n f o @ p h a r m a s o l . c o m m e n t i o n i n g t he d o cu m e n t # < <

Sr.# Details of the non-conformities Ref. clause and expectations Category

evaluation based on the complaints,

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CLASSIFICATION BASIS FOR NON-CONFORMITIES

>> F o r a n y q u e r i e s / c l a r i f i c a t i o n s  i n f o @ p h a r m a s o l . c o m m e n t i o n i n g t he d o cu m e n t # < <

Category Description / Definition

minimum regulatory non-compliance.

INTERPRETATION TO AUDIT CONCLUSION

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Title : Senior GMP consultant

Pharma Sol Limited, UK

Dated: 30th August 2021

>> F o r a n y q u e r i e s / c l a r i f i c a t i o n s  i n f o @ p h a r m a s o l . c o m m e n t i o n i n g t he d o cu m e n t # < <

SECTION III-GMP INSPECTION AND FACILITY TOUR

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Name of the API Material Code Vendor Address

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generated as part of pallet level aggregation is shared to 3PL logistics provider-TRACELINE. On

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Area Conditions under which Background

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Major Equipment in Line _III Capacity Make

Also observed that, an Automatic Inspection machine is installed exclusively in Line-III.

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Vial filling area:

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1. Stirring speed 200 rpm