REPORT ON THE ASSESSMENT OF THE PHARMACEUTICAL QUALITY

SYSTEM AND TECHNICAL EQUIPMENT OF THE ENTERPRISE

І. GENERAL INFORMATION

Enterprise: Pinnacle Life science Pvt Ltd.

Production site of solid forms of non-sterile medicinal products (tablets,

capsules).

Address: Khasra No. 1328-1330, Village - Manpura, Tehsil - Baddi,

Dist. Solan, Himachal Pradesh - 174101 (India)

Report // Pinnacle Life science Pvt Ltd. // India // 10.2019 1/22

Assessed activities: Manufacture of finished medicinal products
Secondary packaging
Laboratory quality control of medicinal products
Batch control and granting of authorization for sale of medicinal
products

Date: 09.10 - 11.10.2019

Regulatory Guideline СТ-Н МОЗУ 42-4.0:2016 Medicinal products. Good

framework: Manufacturing Practice. Order of the MoH of Ukraine No. 798 dated
29.07.2016;
https://zakon5.rada.gov.ua/rada/show/v0095282-09

EudraLex The Rules Governing Medicinal Products in the European Union

Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal
Products for Human and Veterinary Use.
https://ec.europa.eu/health/documents/eudralex/vol-4_en

Auditor: Aleksey Sukhomlynov , expert / consultant GMP / GDP

Report // Pinnacle Life science Pvt Ltd. // India // 10.2019 2/22

 ІІ. DEVIATIONS IDENTIFIED
Deviations, observations, recommendations for elimination and/or comments:
GMP EC
Sr. No. Essence of deviation / violation
clause
1. Pharmaceutical quality system
1 1.10 The procedure for developing
annual product quality reviews
(PQR) provides for the inclusion of
all batches produced if their number
was less than ten, while it does not
indicate how many batches should
be included in the review if the total
number of batches produced is
more than ten.
If the total number of batches
produced is less than three, a
quality review is not developed.
Quality reviews do not display a
review of stability studies.
No statistical methods are used to
assess the stability and
reproducibility of the process.
2. Personnel
One of the elements of
2 2.18 technological garment worn by
the personnel of the production
site is black rubber slippers. The
preparation of these slippers,
before their use, is not described
in the relevant SOP.
3. Premises and equipment
3 3.3, 3.19 In the warehouse, the storage
temperature limit is set as “not more
than 300С”. At the same time,
materials that must be stored at a
temperature of “not more than
250С”, as well as under “cool place”
conditions, are stored in the
warehouse.
Report // Pinnacle Life science Pvt Ltd. // India // 10.2019
Qualification
Comments/Recommendations
of deviation
Minor This approach is not acceptable, since quality
reviews are developed not only for statistical
evaluation of batches produced, but also for
assessing the validation / qualification status,
review of deviations, review of changes in the
product registration status, etc.
Moreover, if less than three batches were
produced in the last year it is recommended that
the batches produced in the previous 2-3 years
(depending on the total number of batches
produced over the period, but not more than 20-
25 batches) be included in the assessment of
stability and reproducibility of the process. Such
an approach, if adopted, should be reflected in
the SOP for preparation of annual quality
reviews.
If there were more than ten batches produced,
then ALL batches should be included in the
product quality review.
To assess the reproducibility of the process, it is
possible to use the reproducibility index – Cpk.
This element of the garment should be included
Minor in the procedures for preparing sets of
garments for work in production premises.
Major To store materials requiring different storage
conditions, it is advisable to use different rooms
or set the temperature in the room with the
lowest value.
Compliance & CAPA Plan
TCD Responsibility
Submitted By M/s pinnacle Life science Pvt. Ltd.
Based on the observation & recommendations, it is decided 15-01-20 Mr. Sandeep
that the SOP governing “Annual Product Quality Review” Bakshi (QA
shall be revised to incorporate the recommended procedural Head)
instructions to cover all the batches of the product
manufactured throughout the calendar year.
Even if less than three batches or no batch manufactured in
the calendar year, then also the APQR will be prepared for
the batches produced in the previous 2 years (depending on
the total number of batches produced over the period) to
review all other QMS aspects related to product like ongoing
Stability Studies, reproducibility of the process, Market
complaints, CAPA implementation review, vendor
qualification review, change controls, deviation, retention
sample review status etc.
Revised SOP will be made effective on or before 15-01-20 &
APQR for year 2019-20 will be prepared as per revised
SOP.
Based on the recommendations & guidance, we will 15-01-20 Mr. Ashok
implement the denim booties instead of rubber shoes for Chawla (HR
the personnel working in the core controlled areas. Head)
The denim booties will be maintained serially in multiple
sets for each person & entire activity will be governed
through standard procedure.
Garment arrangements will be done on or before 15-01-20.
Based on the assessment report, it is decided that the 30-01-20 Mr. Sachin
materials will be stored as per the recommended storage Tyagi (WH
conditions (either provided by vendor/manufacturer or as per Head)
official compendium references).
All the materials are under assessment & verification of the
recommended storage conditions. Based on the verification
report, the required storage conditions will be maintained for
materials storage.
The entire activity towards adherence of storage condition
3/22
 GMP EC Qualification Compliance & CAPA Plan
Sr. No. Essence of deviation / violation Comments/Recommendations TCD Responsibility
clause of deviation Submitted By M/s pinnacle Life science Pvt. Ltd.
will be completed on or before 30-01-20.

4 3.2 In the warehouse for storing raw
materials, the first tier of pallets is
located on the floor. This method of
arranging pallets prevents the
procedure for efficient cleaning of
the floor surface of the warehouse.
Minor Storing pallets on the floor is not recommended, Based on the inspection observations & guidance, it is Mr. Sachin
as pallets will need to be moved for cleaning, decided to install racks system for storage of Materials to Tyagi (WH
which in turn can lead to confusion. avoid direct palletization on the floor. Head)
The racks system will be so designed that cleaning will be
30-01-20
smooth & accessible without physically moving the stored
materials.

The racks system for RM storage in Quarantine & under test

areas will be made functional before 30-01-20.
5 3.4 No means of monitoring the Minor It is recommended to use traps of any type, but As guided by the inspector, the non-poisonous gum trap NA Mr. Sachin
absence of rodents are used in the not poisons for rodents. baits are installed inside the entry points of the Warehouse Tyagi (WH
warehouse. area. Head)
Mr. Ashok
Location chart for the newly installed baits is under Chawla (HR
preparation & procedural instructions for the handling, Head)
checking & cleaning of the same will be incorporated in the
respective SOP for rodent control system.

Changes has been recorded as per change control

procedure for its effective implementation.

Currently we are monitoring rodent process for its

effectiveness.

Required actions has been completed.

6 3.19, 5.10 Primary packaging materials (foil
and film) are stored in a state that
does not preclude their
contamination during storage.
7 3.21 In warehouses for storing finished
products, a system for identifying
the status of finished products is not
used, namely, “Quarantine” and
“Authorized for sale”.
Major Primary packaging materials should be stored
well-packed so as to prevent contact between
the surfaces of the primary packaging materials
and the surrounding area of the warehouse.
Minor For quarantine, it is desirable to have a
separate, clearly defined zone. If a separate
zone is not used, a system for identifying the
status of finished products should be used.
The observation is well taken immediately after inspection & 30-01-20 Mr. Sachin
the primary packing materials have been covered properly Tyagi (WH
with polybag and stored segregated to avoid the chances of Head)
mix-up & contamination.
SOP shall also be revised to incorporate the procedural
instructions & primary packing material receiving checklist
with checkpoints to check the PPM primary packing material
for any damage or exposure during receipt.
Revised SOP will be implemented on or before 30-01-20.
Training has been imparted to concern person for
awareness of contamination and mix up.
Based on the inspection observation & recommendations, 15-01-20 Mr. Sachin
the provision to store the Finished Goods segregated as per Tyagi (WH
status like quarantine, undertest & approved (ready for Head)
dispatch).
SOP for handling & dispatch of Finished Goods will be
implemented with procedural instructions to store the
Finished Goods w.r.t. their status. Dedicated area will be
marked accordingly & training shall be imparted to all
concerned personnel. Required arrangements &
implementations will be completed on or before 15-01-20
Excitingly, finished goods are store and segregated as

Report // Pinnacle Life science Pvt Ltd. // India // 10.2019 4/22

 GMP EC
Sr. No. Essence of deviation / violation
clause
8 3.25 In the warehouse for storing printed
materials, a large number of open
boxes were observed, without
indicating the amount of printed
materials in the box.
9 3.18, 3.19 On the territory of the enterprise
there is another warehouse for
storing finished products. This
warehouse is organized as a room
that directly contacts the street.
Entrance of personnel into this room
is organized through single doors
without any dressing procedures,
the temperature in this room can
easily go beyond the established
limits, since during loading and
unloading operations the doors will
be open.
10 3.2, 5.10 From the secondary packaging
room, air enters the primary
packaging room (II Line).
There is no monitoring of air
pressure drop between the primary
and secondary packaging rooms.
11 3.34 The system of storage and
distribution of purified water has
several disadvantages:
- the air filter is not checked after its
replacement;
- the speed of water in the loop is
not measured;
Report // Pinnacle Life science Pvt Ltd. // India // 10.2019
Qualification
Comments/Recommendations
of deviation
Major Printed products should be treated very strictly
and carefully. Storage should be streamlined;
quantities of packaging materials should be
strictly accounted.
Minor The use of this room as a warehouse for the
storing finished products is not an example of
good practice. It is recommended not to use this
room as a warehouse for finished products.
Major The direction of air movement should be
maintained from the primary packaging room to
the secondary packaging room to prevent
microbiological contamination of products.
Major The water circulation rate should be measured
on return to the storage tank, as an alternative
indicator it is possible to use the value of water
flow (m3/hour).
The recommended storage temperature of
water is no more than 250С.
Compliance & CAPA Plan
TCD Responsibility
Submitted By M/s pinnacle Life science Pvt. Ltd.
suggested for its compliance.
Based on the inspection observation & recommendations, 20-01-20 Mr. Sachin
the SOP for handling of Printed Packaging Materials will be Tyagi (WH
revised to incorporate the Status Label (Loose Quantity) for Head)
systematic controls along with loose quantity inside the box.
The primary packing material will be stored under lock & key
provisions with access control with procedural controls &
instructions to store PPM. Required arrangements &
implementations will be completed on or before 20-01-20
As guided by the expert it is planned to construct an airlock 30-01-20 Mr. Sachin
at the entry point of outer FG Storage area & it is decided Tyagi (WH
that the outer FG Storage area will be dedicated for the FG Head)
Goods which will be ready for dispatch after QP release.
Moreover the area is equipped with air conditioning system
for temperature controls. After construction of Air Lock, the
thermal mapping of the area will be done & monitoring will
be done based on the outcomes of the mapping.
Currently we are maintaining least hold time of goods to
avoid the any impact to deliver goods to customer.
Concerned SOP will be revised & updated accordingly. The
entire activity will be completed on or before 30-01-20.
Based on the observation, the pressure differential issue 30-01-20 Mr. Robin
has been resolved by maintaining the ACPH of respective Lukose
AHU system. Now the air flow is in proper direction. (Projects
Head)
It is decided to install pressure differential monitoring Mr. Harish
gauges between individual primary packaging cubicle w.r.t Senger (PR
secondary packaging hall to monitor the pressure differential Head)
across the primary cubicle & secondary packaging hall.
Respective SOP will be revised accordingly to incorporate
the monitoring procedure & logging of the pressure
differential .
Additionally the as a preventive measures Line clearance
checklist & Inprocess monitoring checklist of BPR will also
be revised to incorporate the checkpoint to verify the
pressure differential during initial line clearance activity & at
defined frequency throughout the packing operations. Entire
activity will be completed before 30-01-20.
As guided by the expert, it is decided that the SOP for Management Management
purified water system Tank vent filter replacement will be Decision Decision
Required
revised to incorporate the procedural instructions & Required
frequency to check the vent filter integrity before
replacement to ensure that the vent filter was well within
required integrity throughout the installation period.
5/22
 GMP EC
Sr. No. Essence of deviation / violation
clause
- the storage temperature of purified
water is equal to the ambient
temperature.
12 3.34 To obtain compressed air, two
compressors are used, one of which
in its design feature involves the use
of a significant amount of oil/grease,
which can enter the compressed air.
Report // Pinnacle Life science Pvt Ltd. // India // 10.2019
Qualification Compliance & CAPA Plan
Comments/Recommendations TCD Responsibility
of deviation Submitted By M/s pinnacle Life science Pvt. Ltd.
In addition to this, the purified water system Tank vent filter
assembly has been replaced with EHFA (Electrical Heater
Filter Assembly) which keeps the vent filter above 800C,
eliminating the chances of microbial growth at filter.
The water flow speed meter has been installed & governed
by centralized PLC system with online data backup &
privilege controls.
Reference Copy of the report is attached as Annexure-
11(1). Photograph of Flow meter is attached as Annexure-
11(2).
For storage temperature, On detailed assessment of the
existing system & discussion with the concerned personnel
& discussion with the hired subject matter experts /
outsourced consultants, it is revealed that the existing
system does not have any provision to restrict the water
temperature below 25oC in loop system. Thus the previous
reports & history & trend data of water system reviewed &
assessed & revealed that the water generated with the
existing system has never been failed for chemical, viable &
non-viable parameters. Furthermore the Raw water, Soft
Water reports are also assessed & found that there is no
failure of water reported throughout the system lifecycle in
the past. Observed results for all chemical & microbiological
parameters are well within trends & specifications. Hence
from the historic review it can be concluded that the existing
system & controls are capable enough to generate the
quality purified water which complies the international norms
& standards for PW.
The existing water system has PLC controlled / operated
online monitoring systems with auto dumping system to
ensure the rejection of water which fails for conductivity, pH,
TOC. Specifications.
Furthermore the daily monitoring of water for chemical as
well as microbiological parameters and weekly hot
sanitization system are in place to ensure the use of water
which meets the defined standards.
Thus as of now being Manufacturer of General (Non Sterile)
Category Oral Solid, Oral Liquids & External Preparations, it
can be concluded that the existing water system & controls
are efficient enough to generate & ensure the quality
standards for water for pharmaceutical use. However the
recommended upgradation by the inspector is well
considered & included in future upgradation plan , which will
be prioritized on requirement basis w.r.t trend data.
Major Since compressed air has direct contact with As per observation & recommendations, the SOP & Protocol 15-02-20 Mr. Robin
the product, its quality is of great importance. Air for compressed air monitoring will be revised & updated to Lukose
testing should be carried out periodically incorporate the periodic monitoring of the compressed air (Projects
according to the indicators and methods coming in direct contact with product & equipment contact Head)
described in ISO 8573. parts inline with ISO 8573 requirements. Mr. Sandeep
6/22
 GMP EC Qualification Compliance & CAPA Plan
Sr. No. Essence of deviation / violation Comments/Recommendations TCD Responsibility
clause of deviation Submitted By M/s pinnacle Life science Pvt. Ltd.
The efficiency of the filter on the On existing system review by the concerned technical Bakshi (QA
compressed air supply line is not personnel & outsourced technical experts, it is noticed that Head)
checked. the existing system has oil & moisture trap with 0.5μ air filter
Pipes made of ordinary steel (not at inlet to air drier & a filter of 0.003μ filter is installed at
stainless steel) are used for the outlet of air drier, prior to distribution to user points through
compressed air transportation SS 316 pipes. The final filter of 0.003μ is efficient than the
system, which can create a risk of recommended 0.1μ filter.
rust entering compressed air. Further the ordinary steel pipe observed by the inspector is
the part of supply line from compressor to filter unit. After
0.003μ filter unit, the supply line is of SS 316, but the concerned
personnel could not explain the same to the inspector. Hence it is
also decided to replace the GI Part of the supply line with
SS 316 & will be taken in to consideration during future
upgradation plan.
Periodic monitoring of air for viable & non viable parameters
from each user point will be implemented in the SOP &
Protocol.
The proposed activities & actions will be completed &
implemented before 15-02-20.
13 3.34, 3.38, For air treatment sets for granulation Minor These tests are mandatory. As guided by the auditor & Outsourced subject matter NA Mr. Sandeep
5.10 (FBD) and tablet coating equipment, experts, the Filter Integrity Testing Schedule has been Bakshi (QA
HEPA filters are not checked for revised to incorporate the FBD & Autocoater HEPA Filter to Head)
integrity and tightness of the test & check the integrity & intactness of filters. The integrity Mr. Robin
installation. testing has been done as per schedule in last week of Lukose
December 2019. (Engg. Head)
Copies of Filter Integrity test report / certificate are attached Mr. Harish
as Annexure-.13.1 (3.34, 3.38, 5.10) Senger (PR
Copy of the Filter Integrity Testing Schedule is attached as Head)
Annexure-13.2 (3.34, 3.38, 5.10)
14 3.19 The study of temperature Major Tests should be carried out in the hot and humid As recommended by the inspector & referring the Completed Mr. Sandeep
distribution (mapping) in the season. recommended guidance documents, the SOP for Bakshi (QA
premises of quarantine storage of Temperature Mapping has been revised to incorporate the Head)
raw materials has not been required procedural instructions & seasonal mapping Mr. Robin
performed. schedule. Lukose
(Engg. Head)
Based on the revised SOP, the protocol for mapping has
been prepared with incorporation of seasonal mapping plan
of the areas. Mapping has also been done for winter
season.

Based on the protocol & schedule, the mapping activity will

be repeated in Summers & Spring seasons also.

Copy of the Protocol along with schedule is attached as

15 3.1, 5.10 Instruments used for weighing raw
materials are washed and dried in
an unclassified room; the supply of
prepared and clean air is not
provided for in this room.
Annexure-14 (3.19)
Critical Preparation of instruments that have direct The observation has been taken under consideration 28-02-20 Mr. Robin
contact with the product should be carried out in immediately after the inspection & as per Action Plan Lukose
clean rooms or sterilized after preparation. designed for compliance; the washing area will be (Engg. Head)
constructed outside the dispensing area in warehouse
premises with adequate environmental & access controls.

Area location & design with execution plan has been

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 GMP EC
Sr. No. Essence of deviation / violation
clause
16 3.34 The chamber used for storing
samples for the further stability
studies program was qualified
without being fully loaded with
samples.
5. Technological process
17 5.23 Technological process parameters
that were confirmed during
validation do not always correspond
to the parameters used in routine
production.
For example, for the medicinal
product Ciprofloxacin 500, during
validation the mixing time was
confirmed – 30 minutes, and in the
routine production the duration of
the process was 25 minutes; tablet
press rotation rate during validation
it is not known, and the rotation rate
from 16 to 20 rpm is used in the
routine production; the speed of the
packaging machine is not known
both during the routine production
and validation.
Report // Pinnacle Life science Pvt Ltd. // India // 10.2019
Qualification Compliance & CAPA Plan
Comments/Recommendations TCD Responsibility
of deviation Submitted By M/s pinnacle Life science Pvt. Ltd.
prepared & sent for final approval from Corporate Quality, &
Hired GMP Experts & Management. The entire activity is
expected to be completed on or before 28-02-20.
Copy of the proposed layout is attached as Annexure-
15(3.1, 5.10)
Till the completion of the proposed Action Plan, the
cleaning & washing of the instruments will be done in the
existing area with utmost care & additional activity of
sterilization of the instruments with 70% IPA after cleaning &
final rinsing with PW.
Major Qualification should be carried out in the worst As guided by the inspector & w.r.t. GMP requirements, the 10-03-20 Mr. Sandeep
case scenario. qualification of the existing stability chambers has been Bakshi (QA
done with maximum load & the qualification has been Head)
completed successfully.
Reports of the qualification activity are attached as
Annexure-16(3.34).
SOP & protocol for Stability chamber Qualification has been
revised for scope, criteria & schedule for qualification.
Draft Copy of revised SOP & Qualification Protocol along
with schedule are attached as Annexure-17(3.34).
In addition to this, it is decided to install the additional walk
in stability chamber in accordance with existing
requirements & future prospective. The walk-in stability
chambers are expected to be received at site by 15-02-20 &
will be made available for routine stability sample charging
with qualification & mapping activity completion with
consideration of worst case scenario before 10-03-20 .
Major All process and equipment operation Based on the inspection observation & guidance received 30-12-19 Mr. Sandeep
parameters must be confirmed during validation. from experts, the observed discrepancy is taken for impact Bakshi (QA
Accordingly, all values must coincide, the assessment & the product documents are reviewed for Head)
minimum and maximum values of the synchronization with validation report. BMR/BPR used for
parameters must be checked, if such a post validation batches manufacturing couldn’t been revised
possibility is allowed during the routine w.r.t. validation report & the parameters were not freezed &
production. further 4 more batches were manufactured with validation
Statistical methods such as ISO2859 should be batch’s BMR/BPR without freezing the parametric limits.
used to prepare a sampling plan during
validation. However it is observed that the process of post validation
batches was carried out in line with the validated parameters
but the values for parameters are handwritten instead of
pre-printed fixed parametric limits, which are supposed to be
pre-printed in post validation batch BMR.
Now based on the investigation outcomes, the SOP &
Report form for Process validation has been taken under
revision to incorporate the procedural instructions &
8/22
 GMP EC
Sr. No. Essence of deviation / violation
clause
18 5.23 During sterilization validation in the
autoclave, only biological indicators
were used without the use of
temperature measurement.
20 5.20 When calculating the maximum
possible medicinal product residues
on the equipment surface, the
toxicological properties of the
products were not used.
21 3.6, 5.20 When determining the inaccessible
places for cleaning equipment, no
studies were conducted, and the
Report // Pinnacle Life science Pvt Ltd. // India // 10.2019
Qualification
Comments/Recommendations
of deviation
Major
Major When calculating medicinal product residues
one should use the Guideline on setting health
based exposure limits for use in risk
identification in the manufacture of different
medicinal products in shared facilities.
https://www.ema.europa.eu/en/documents/scien
tific-guideline/guideline-setting-health-based-
exposure-limits-use-risk-identification-
manufacture-different_en.pdf
Major For each unit of equipment, an assessment /
determination of places difficult to access for
cleaning should be performed. One of the
Compliance & CAPA Plan
TCD Responsibility
Submitted By M/s pinnacle Life science Pvt. Ltd.
conclusive details of final parameters & effective BMR/BPR
with incorporation of validated parameter’s limits.
In addition to this the SOP for preparation of BMR/BPR shall
also be revised to incorporate the procedural instructions to
print the Validation Batch’s BMR/BPR with bold watermark
as “FOR VALIDATION BATCH ONLY & NOT TO BE USED
FOR ROUTINE PRODUCT MANUFACTURING”, which will
prompt the user or issuing personnel for the status of
BMR/BPR for validation or post validation batch.
Furthermore, the policy shall also be revised to incorporate
the instructions to take post validation / routine batches
manufacturing plan after completion of validation activity &
revision of BMR/BPR.
Entire activity of document revision & implementation will be
completed on or before 30-01-20.
Based on the observation, detailed investigation is carried 15-04-20 Mr. Manoj
out & it is observed that the existing autoclave is an old Sharma (QC
model in which there is no provision of sensor insertion for Head)
temperature mapping thus the physical temperature
qualification couldn’t be performed for the available
autoclave.
However the sterilization monitoring is being done with
chemical indicator / biological indicators and by using
positive control & negative control of media. In addition to
this the autoclave has pressure indicator from which we
assure the sterilization with temperature pressure co-
relation.
Further the microbiology laboratory is also under expansion
& new autoclave with latest requirements compliance is
under procurement & expected to be completed 15-04-20.
The proposed autoclave will be with PLC governed controls
& online data Inquisition system.
Based on the guidance & reference documents, It is decided 30-12-19 Mr. Sandeep
to revise the Cleaning Validation Policy to incorporate the Bakshi (QA
PDE/HBEL criteria for selection, assessment & calculation & Head)
of the maximum possible medicinal product residues on the
equipment surface, allowable carryover w.r.t. toxicological 30-03-20
properties of the products.
The SOP & Protocol for Cleaning Validation has been taken
under revision to incorporate the same. On revision of
respective documents, the cleaning validation activity will be
carried out as per revised SOP & Protocol. The revised
documents will be made effective before 30-12-19 & the
cleaning validation activity will be completed on or before
30-03-20.
As guided & recommended by the expert inspector the SOP 30-12-19 Mr. Sandeep
& Protocol for Cleaning Validation has been taken under Bakshi (QA
revision to incorporate the Riboflavin Test for identification of & Head)
9/22
 GMP EC Qualification Compliance & CAPA Plan
Sr. No. Essence of deviation / violation Comments/Recommendations TCD Responsibility
clause of deviation Submitted By M/s pinnacle Life science Pvt. Ltd.
conclusion was made on the basis commonly used methods for finding inaccessible places / parts of the equipment. These
of ideas and knowledge about the inaccessible places is the Riboflavin test. incorporation will be done along with the Action Plan 30-03-20
equipment. proposed in above point (Point No. 20).

On revision of respective documents, the cleaning validation

22 Annex 15 A procedure has not been
5.28 - 5.32 developed for conducting Ongoing
Process Verification.
23 Annex 15 Verification of transportation of
6.1 - 6.4 finished products has not been
carried out. There is no procedure
for conducting such verification.
24 5.27, 5.29 A system for assessing and
approving raw material suppliers
has not been developed.
Major Regardless of the method used to validate the
process, ongoing verification should be carried
out. Frequency and volume can be selected by
the manufacturer based on knowledge of the
process, past results, etc.
Major Taking into account that there were still no
deliveries to Ukraine, it will be enough to
provide a prepared written procedure by which
transportation verification will be carried out. It is
possible to demonstrate the results of deliveries
to other markets; this will be perceived positively
as a demonstration of the company's abilities.
Minor Raw material suppliers should be approved.
activity will be carried out as per revised SOP & Protocol &
Riboflavin Test will be carried out to find HTC / HTA places /
Parts of the equipments. The revised documents will be
made effective before 20-12-19 & the Cleaning Validation
activity will be completed on or before 30-03-20.
As per the guidance from inspector & reference from 30-01-20 Mr. Sandeep
guidance documents, it is decided to incorporate the Bakshi (QA
concurrent process validation policy at site. SOP & Protocol Head)
for the CPV is under preparation & expected to be
completed & implemented before 30-01-20.
As per the guidance from inspector & reference guidance 15-01-20 Mr. Sandeep
documents, it is decided to incorporate the policy for Bakshi (QA
Verification of Transportation of Finished Products at site. Head)
SOP & Protocol for the same is under preparation &
expected to be completed & implemented before 15-01-20.
Based on the recommendations, it is decided to perform the
verification activity for current supplies after approval from
Corporate Quality .
Based on the guidance received from inspector & reference 30-03-20 Mr. Yogesh
documents, we have initiated supplier audit immediately Gangawane
through our Corporate Quality Assurance& Purchase (CQA Head)
department, few highly material supplied vendors/suppliers
has been audited for its approval, rest under process will be
completed on or before 28.02.2019.

Furthermore it is decided that the Vendor Qualification

Policy / SOP will be revised for detailed & clear procedural
instructions for the vendor qualification & requalification.
Entire activity will be governed by Corporate Quality
Assurance team under CQA Head lead. The decided Action
Plan will be implemented on or before 28-02-20 with revised
SOP & Schedule. Vendor Agreements will also be revised
w.r.t. revised SOP & Schedule.

25 5.27 When receiving raw materials at the Major For each of the materials, the supply chain Based on the guidance received from inspector & reference 15-01-20 Mr. Yogesh
enterprise’s warehouse, the should be approved, and each time raw documents, we have initiated supplier audit immediately Gangawane
conformity of the supply chain is not materials are received at the warehouse, it is through our Corporate Quality Assurance& Purchase (CQA Head)
checked. necessary to check compliance and give an department, few highly material supplied vendors/suppliers
assessment. has been audited for its approval, rest under process will be Mr. Sachin
completed on or before 28.02.2019. Tyagi (WH
SOP for Incoming Materials Controls / Receipt of RM will be Head)
revised for detailed & clear procedural instructions for the
qualification & Approval of Supply chain.
Also the checklist for receipt of RM shall also be revised to
incorporate the provision of assessment of incoming
materials for standard compliance. Entire activity will be

Report // Pinnacle Life science Pvt Ltd. // India // 10.2019 10/22

 GMP EC Qualification Compliance & CAPA Plan
Sr. No. Essence of deviation / violation Comments/Recommendations TCD Responsibility
clause of deviation Submitted By M/s pinnacle Life science Pvt. Ltd.
implemented before 15-01-20.
26 Annex 16 For issued authorizations for sale of Minor For issued authorizations the register should be As guided by the inspector, the SOP for “Issued 20-01-20 Mr. Sachin
1.10.1 finished product batches the maintained, for example, in the form of a log. Authorizations for Sale of Finished Product Batches” will be Tyagi (WH
corresponding registers are not implemented with the provision of Log form to maintain the Head)
maintained (for example, in the form Issued Authorizations for Sale of Finished Product Batches.
of a log).
The SOP & record log will be implemented before 20-01-20
27 5.10 In the production area, plastic bags Minor Since these plastic bags have direct contact Based on the recommendations & requirements, SOP, NA Mr. Manoj
are used for storing intermediate with the product and parts of the equipment, Specification & STP has been implemented for testing of Sharma (QC
products and packaging parts of which in turn have contact with the product, plastic bags for chemical & microbiological Quality Head)
equipment for their storage. these bags should be subjected to incoming parameters along with physical parameters (already
However, no incoming quality quality control, especially in terms of implemented procedure for physical inspection, dimension
control of these bags is carried out. “Microbiological purity”. verification & receipt of bags only along with Food Grade
Declaration Certificate from the vendor) which comes in
direct contact with the product / materials.

SOP, Specification & STP for the same has been

implemented 07-01-20..

Copy of the SOP & revised Specification and STP attached

as Annexure -5.10
6. Quality control
28 6.36 The assessment of the further Minor The assessment of trends can be an effective As guided & recommended by the expert, the SOP for NA Mr. Manoj
stability studies program is tool when summarizing intermediate results. Stability Studies has been taken under revision to Sharma (QC
supposed to be carried out at the incorporate the procedural instructions & provision of Head)
end of the program and not once the assessment along with trending of each station / interval Mr. Sandeep
results are available at each stage data in the report form. Bakshi (QA
of the program. Revised SOP & forms are drafted & awaiting for receipt of Head)
printed bounded logbooks which are given for printing to
outsourced printing service provider and are expected to be
received on or before 15-01-20 & will be implemented
immediately.
Draft Copy of revised SOP is attached as Annexure-6.36
29 5.10 No incoming control is carried out on Major - Based on the recommendations & requirements, SOP, NA Mr. Manoj
the indicator “Microbiological purity” Specification & STP has been implemented for testing of Sharma (QC
of plastic bags, which are used to plastic bags for chemical & microbiological Quality Head)
pack clean parts of equipment that parameters along with physical parameters (already
come into direct contact with implemented procedure for physical inspection, dimension
products. verification & receipt of bags only along with Food Grade
Declaration Certificate from the vendor) which comes in
direct contact with the product / materials.

SOP, Specification & STP for the same has been

implemented 07-01-20..

Copy of the SOP & revised Specification and STP attached

30 Annex 11: The practice of verification the audit
9 trail of analytical studies involves the
verification by the operator who
conducted the analysis.
as Annexure -5.10
Major The verification procedure should be clearly Based on the recommendations & guidance from inspector, 30-01-20 Mr. Manoj
defined and described in the SOP. The fact of the SOP for “Audit Trail Management” will be revised for Sharma (QC
such an assessment and the result of the incorporation of audit trial verification procedure along with Head)
assessment should be recorded. the Audit Trail Checklist with detailed must checkpoints to

Report // Pinnacle Life science Pvt Ltd. // India // 10.2019 11/22

 GMP EC Qualification Compliance & CAPA Plan
Sr. No. Essence of deviation / violation Comments/Recommendations TCD Responsibility
clause of deviation Submitted By M/s pinnacle Life science Pvt. Ltd.
The verification must be performed either by a be checked & reviewed by the reviewer for effective review
second laboratory technician or by the head of of audit trail. The revised SOP & Checklist will be made
the laboratory team. effective & implemented before 30-01-20.

In addition to the Second line review by senior QC Reviewer

& Final Review By Laboratory Head, it is decided to depute
an independent Quality Assurance function under Site
Quality Head to review the same on daily basis for its
compliance. One Candidate with QC Background has been
joined & deputed in the QC Laboratory for review on behalf
of QA Function in QC Lab.
Moreover the QC IT Expert for QC support will also be deputed in
QC before 30-01-20.
31 6.8 The analysis results for Ibuprofen Critical This situation can be evaluated as falsification Based on the observations & guidance from the experts, it is 30-12-19 Mr. Manoj
contain test data from the contract of data. decided that the SOP governing the Contract Analysis Sharma (QC
laboratory (Auriga). At the same Services Utilization will be revised to incorporate the defined Head)
time, there is no certificate of procedure for receipt of analysis reports from Contract
analysis from the contract Analysis Laboratory in defined format with identification &
laboratory. coding on the reports which authenticate the originality &
legality of the report received through Electronic Media
(Mails).

Also the instructions to confirm, review & verify the

32 5.10 Instruments used for sampling raw
materials are washed and dried in
an unclassified laboratory room.
Critical Instruments that have direct contact with the
product should be prepared in clean rooms or
sterilized after preparation.
complete analysis data along with Contract Analysis
Laboratory COA for the tests carried out by outsourced
Contract Analysis Laboratory in original copies prior to
approve the material / batch.
In addition to this, the review of Contract Analysis
Laboratory reports & compliance of the established
procedure along with review checklist will also be
incorporated in SOP. The planned activities will be
completed & implemented before 30/12/19
The observation has been taken under consideration 28-02-20 Mr. Sandeep
immediately after the inspection & as per Action Plan Bakshi (QA
designed for compliance, a new washing area will be Head)
constructed outside the dispensing area in warehouse
premises with adequate environmental & access controls. Mr. Robin
Area location & design with execution plan has been Lukose
prepared & sent for final approval from Corporate Quality (Engg. Head)
Expert & Hired GMP Expert consultant. The entire activity is
expected to be completed before 28-02-20.

Copy of the proposed layout is attached as Annexure-15

(3.1, 5.10)

Till the completion of the proposed Action Plan, the

cleaning & washing of the sampling equipments will be done
in the existing washing area of Warehouse with utmost care
& additional activity of sterilization of the tools with 70% IPA
after cleaning & final rinsing with PW.
33 5.33 The contents of each container for Major The identification requirement applies to both The matter is under consideration & assessment with 30-03-20 Mr. Sandeep
excipients are not identified. active substances and excipients. Technical Experts & Corporate Quality Experts for feasibility Bakshi (QA

Report // Pinnacle Life science Pvt Ltd. // India // 10.2019 12/22

 GMP EC
Sr. No. Essence of deviation / violation
clause
34 5.33 The analysis results for the active
substance Paracetamol authorized
for use do not contain the results of
the identification test of 80 bags that
were received in one delivery.
Report // Pinnacle Life science Pvt Ltd. // India // 10.2019
Qualification Compliance & CAPA Plan
Comments/Recommendations TCD Responsibility
of deviation Submitted By M/s pinnacle Life science Pvt. Ltd.
& way out for implementation for the Excipients. Head)
Mr. Robin
The required arrangements for implementation are being
assessed like provision of additional sampling booth or
installation of NIR. The finalization of Action Plan &
implementation will be updated on or before 30-03-20.
Accordingly the SOP & other related documents / forms will
be revised & updated.
Critical On detailed investigation, it is revealed that the concerned 20-01-20 Mr. Manoj
analyst had to complete the analysis on individual container Sharma (QC
samples separately / individually for Identification test as per Head)
STP. But the concerned analyst overlooked the Standard
Test Procedure and performed the identification testing on
composite sample. On trail review, it’s also confirmed that
the identification testing was carried out on single sample for
the consignment & same is reported in the report.
On further investigation & initial impact assessment, it is
revealed that the Material was received from regular
approved vendor & all the testing has been done on
composite sample of the entire consignment & results found
complying with specifications & well with in the trend results
of the previous consignments from the vendor.
On stock details verification, it is found that the entire
consignment has been consumed in product manufacturing.
Thus the analysis data of all the batches in which the said
consignment been consumed are reviewed & found well
complying with the standard established parameters.
Based on the initial outcomes & discussion with concerned
analyst, detailed assessment carried out as :
The samples of the batches in which the particular
consignment API used are assessed in depth by reviewing
the related documents & analysis reports for comparison of
the Finished Goods Sample Identification / Assay results
w.r.t RM test results generated on composite sample. The
comparison results found within standard specifications &
within trends of previous batches & consignments of API.
Further the previous consignments analysed by the same
analyst are also reviewed & assessed for the similar
discrepancy, but there is no other API consignment found
analysed for Identification on composite sample. Rest of all
consignments found tested for identification test on
individual container sample.
Thus it may be concluded that the material used in the batch
manufacturing was of specified standard & quality
parameters & there may be no impact on the SISPQ of
Finish Product batches manufactured using the said
consignment of the API.
Further to avoid such discrepancies in future, the SOP for
Analysis, Review & Approval of Data & Test Data / raw data
results are taken under revision to incorporate the
procedural instructions & checklist for review & approval of
analysis data prior to release the Material for batches. In
13/22
 GMP EC
Sr. No. Essence of deviation / violation
clause
35 6.21 The laboratory does not have a
certificate for a working reference
standard of Ciprofloxacin.
36 6.24 Two autoclaves are installed in one
room of the microbiological
laboratory: for sterilization and for
decontamination of “contaminated”
materials. The simultaneous use of
these autoclaves can lead to
microbiological contamination of
sterilized materials.
There is no procedure or any
visualization at the workplace about
the types of charges of the
autoclave used for sterilization.
37 6.7 There is no formalized sampling
plan for microbiological monitoring
of production facilities.
For monitoring, only the
sedimentation method on Petri
dishes is used.
Report // Pinnacle Life science Pvt Ltd. // India // 10.2019
Qualification Compliance & CAPA Plan
Comments/Recommendations TCD Responsibility
of deviation Submitted By M/s pinnacle Life science Pvt. Ltd.
addition to this, review by Second Line Sr. Analyst
Reviewer, Lab Head & Independent QA (AQA) Person have
been implemented for online review of QC activities w.r.t.
established procedures.
The concerned personnel have been strictly instructed to
follow the standards established procedures without any
deviation & failing to which will result in strict disciplinary
actions including termination from employment & legal
actions. The matter has been shared with all QC personnel
to make them aware regarding the issue and vigilant during
work.
The proposed revision of SOP will be completed &
implemented before 20-01-20.
Minor An appropriate certificate should be available for Based on the guidance & requirements, the SOP for 15-01-20 Mr. Manoj
all reference standards, especially for those that Handling of RWS is taken under revision to incorporate the Sharma (QC
are working standards and are not receipt of qualification COA along with RWS at site. Head)
Pharmacopeial.
Qualification Certificates for the all available lots of RWS
have been availed at site QC Lab. Revised SOP will be
made effective before 15-01-20.
In addition to this, the online cross functional review of QC
Activities by QA Function has been implemented to ensure
the compliance of the established procedures & GLP.
Major Separation of use of this equipment in time is As guided by the experts, the SOP has been taken under 30-03-20 Mr. Manoj
possible, but at the same time this requirement revision to incorporate the procedural instructions to Sharma (QC
should be clearly regulated in the SOP, and the regulate the use of individual autoclave at a time without Head)
fact of compliance with this requirement should overlapping the activity of each other. Also the log record for
be recorded and evaluated. the same will be maintained to avoid the simultaneous use
of both autoclaves at one time.
Moreover the microbiology laboratory is also under
expansion & new area will have dedicated areas for each
autoclave ,which is expected to be completed 30-03-20.
Microbiological lab will be completely restructured to ensure
compliance of regulatory as well as GLP/GMP requirements
& to overcome the existing space constrains in current
microbiology lab.
Till the new proposed microbiology area will be functional,
the existing systems will be strictly followed to avoid
concerned issues in present system.
Copy of proposed Layout of Microbiology Lab is attached as
Annexure-36(6.24).
Minor For monitoring, we recommend to consider The SOP is under revision & updation to incorporate the 30-01-20 Mr. Manoj
other sampling methods: active air sampling required Schedule / sampling plan for microbiological Sharma (QC
(aspiration method), sampling from surfaces monitoring of each production area. Sampling techniques 15-01-20 Head)
and personnel. like active air sampling (aspiration method), sampling from
surfaces and personnel recommended by the expert will
also be incorporated and implemented before15-01-20.
Procurement process for active air sampler has also been
14/22
 GMP EC Qualification Compliance & CAPA Plan
Sr. No. Essence of deviation / violation Comments/Recommendations TCD Responsibility
clause of deviation Submitted By M/s pinnacle Life science Pvt. Ltd.
initiated & expected to be received before 30-01-20.
38 5.10 There is no incoming control of Major Since these gloves are non-sterile, there is no It is decided to incorporate the practice & procedure of 20-01-20 Mr. Manoj
gloves that the personnel use in information on how they can be contaminated, testing of hand gloves used in the process areas which Sharma (QC
production rooms and which have periodic monitoring is necessary. It is advisable comes in direct contact with the materials / products & Head)
direct contact with products. to audit the gloves manufacturer. equipments contact parts.
SOP for the same will be implemented. Specification & STP
for gloves will be implemented to incorporate the physical,
chemical & Microbiological assessment / testing of the
gloves.
However in current situation the physical inspection,
verification & receipt of gloves along with Food Grade
Declaration Certificate from the vendor is in practice &
mandate.
Further vendor qualification for the same is under experts
assessment for feasibility & execution plan & same will be
updated before 20-01-20.
The SOP, Specification and STP for Gloves will be made
effective before 20-01-20.
39 6.15 The effectiveness of the "Hand Minor - As guided, the protocol for the qualification of hand sanitizer 30-01-20 Mr. Manoj
Annex 15: Sanitizer" used by the personnel for for its effectiveness has been prepared & the activity of Sharma (QC
9.2 handwashing has not been tested. qualification will be immediately started after approval & Head)
effectiveness of protocol.
The preparation of protocol & qualification activity is
expected to be completed before 30-01-20.
40 6.15 Verification of the methods used in Major All methods should be verified by the laboratory As per directions & guidance of experts the protocol for RM 15-01-20 Mr. Manoj
the quality control of raw materials where these methods are used. & FP testing methods verification has been implemented & Sharma (QC
and finished products is not carried the verification activity is under process. Head)
out.
For microbiological methods of Further the protocol for Microbiological Analysis Method
quality control, validation Verification is under preparation & finalization. Once the
(verification of the suitability of the protocol will get approved & effective, the verification activity
method) has not been performed. will be initiated immediately. The implementation of the
protocol is expected to be completed before 15-01-20.
7. External (outsourcing) activities
41 7.4, 7.5, During the audit and approval of the Minor It is necessary to check these circumstances Based on the inspection observations & experts guidance, it 30-01-20 Mr. Sandeep
7,7 contract laundry, the fact was not and prepare sufficient evidence of the absence is decided to revise the Laundry Qualification Protocol to Bakshi (QA
established that there was no risk of of such a risk. incorporate the risk assessment for the chances of cross Head)
cross-contamination of clothes with contamination of cloths at outsourced laundry. After revision
medicinal products that of the protocol, the outsourced laundry service providing
contaminated clothes brought for facility will be re-audited to assess the possible risks of
washing from other enterprises. The contamination & existing controls.
quality agreement does not The quality agreement will also be revised to incorporate the
establish the requirement not to terms & conditions w.r.t the requirements not to wash the
wash the clothes of the enterprise clothes of our firm together with clothes from other firms in
together with clothes from other any case. The entire activity will be completed before 30-01-
enterprises that produce, for 20
example, penicillin or cephalosporin Till the implementation of the proposed upgradation in
antibiotics. systems & SOP, the current laundry audit schedule is being
followed with consideration of suggested points & audit
carried out on 07-01-20 & report is under compilation.As per
audit team the Laundry is with acceptable controls &

Report // Pinnacle Life science Pvt Ltd. // India // 10.2019 15/22

 GMP EC Qualification Compliance & CAPA Plan
Sr. No. Essence of deviation / violation Comments/Recommendations TCD Responsibility
clause of deviation Submitted By M/s pinnacle Life science Pvt. Ltd.
detailed report & desired action plan will be shared with the
Laundry before 20-01-20.
42 7.4 To manage outsourcing activities Minor There should be a clear written procedure for As guided by the expert, the SOP for Outsourced Activities 30-12-19 Mr. Sandeep
there is no procedure that describes this type of activity. Management is under preparation & expected to be Bakshi (QA
the Action Plan. completed & implemented before 30-12-20. Head)

8. Complaints, quality defects and recalls

43 8.30 The effectiveness of recall / training Minor Effectiveness assessment can be carried out The SOP governing Recall / Mock Recall / Training Recall is 30-01-20 Mr. Sandeep
recall procedures is not assessed. both for training and for real recall procedures, under revision to incorporate the procedural instructions to Bakshi (QA
the approach to the assessment should be assess the effectiveness of Recall procedure by carrying out 30-03-20 Head)
included in the written procedure. periodic mock / training recall activity by considering
It is recommended to conduct a training recall possible hurdles in the recall process like weekend /
also on a weekend / holiday. holidays etc.

The revised SOP has been shared with CQA Experts for
review & feasibility assessment & will be made effective
before 30-01-20 & execution will be carried out before 30-
03-20.

Report // Pinnacle Life science Pvt Ltd. // India // 10.2019 16/22

ІІІ. Additional comments / recommendations
Sr. No. Comments / Recommendations
1. Conducting a company presentation at the first meeting with the
inspectors, presentation content. The first impression depends
on the presentation of the company, which is held at the first
meeting with the inspectors, and it can be very important. The
presentation should include information on the pharmaceutical
quality system of the enterprise and its main elements, policies
and goals in the field of quality. It will also be useful to separately
present the key personnel of the company with an indication of
education, work experience, achievements in the past,
completed additional education. In addition, during the
presentation it is very useful to explain what is located in the
territory of the enterprise and where the main objects of
inspection are located, to list the available sites, basic
equipment, and systems. Sales should not be indicated in the
presentation, but it is useful to provide information about the
markets into which the company's products are exported.
2. For all visitors, regardless of their status, a unified training
system should be provided before admission to “clean”
production facilities. It is good practice to ask visitors about their
health status during admission. When visiting production
facilities, someone of the company personnel should always go
first and show/explain actions for guests.
3. To develop a sampling plan for raw materials and packaging
materials, it is recommended to use the ISO 2859 standard. The
same approach applies when developing a sampling plan for
technological process validation.
4. When approving manufacturers and suppliers (distributors) of
active pharmaceutical ingredients (API), their audits is a
prerequisite. Only after approval can they appear in the List of
Approved Suppliers.
5. Each supply of raw materials and packaging materials
(admission to the warehouse) should be evaluated in terms of
supply chain compliance. To do this, the enterprise must have
an approved supply chain for each item.
Report // Pinnacle Life science Pvt Ltd. // India // 10.2019
Action Plan : Responsibility TCD
As guided by the Inspection Expert, the firm presentation is Mr. Sandeep Bakshi 15-01-20
under revision to more elaboration/addition of the
pharmaceutical quality system of the enterprise and its main
elements, policies and goals in the field of quality etc. taken by
QA (Mr. Sandeep Bakshi) for suggested upgradation &
recommendations. The existing presentation was provided by
Corporate Quality Assurance & includes more details of Parent
company i.e. M/s Aarti Industries Ltd. & like more detailed w.r.t.
marketing promotions. The proposed updations in the
presentation will be implemented before 15-01-20.
As guided by the Inspection Expert, the recommended Mr. Ashok Chawla 30-12-19
updations will be implemented through defined QMS (HR Head).
procedures applicable. Specific policy will be defined in the
SOP under HR (hospitality & coordination controls) department
with detailed unified training system for visitor’s (including own
firm employees from Corporate Team who visits the site).
proposed SOP & implementation will be completed on or before
30-12-19
As guided by the Inspection Expert, the respective SOP will be Mr. Manoj Sharma 30-01-20
revised for recommended updations in the SOP. For Sampling (QC head)
SOP, QC Dept. will revise respective SOP & for Process
Validation, QA Dept. will revise the SOP for Process Validation. Mr. Sandeep Bakshi
(QA Head)
The revision & implementation of revised SOP will be done
before 30-01-20
As guided by the Inspection Expert, the recommended Mr. Yogesh (CQA) 28-02-20
updations are being reviewed & implementation Action Plan
will be designed & completed before 28-02-20.
As guided by the Inspection Expert, the recommended Mr. Sandeep Bakshi 30-01-20
updations will be incorporated in the system procedures & SOP (QA Head)
will be prepared & implemented for the same. SOP preparation
will be done before 30-01-20 (By site QA) & implementation Mr. Yogesh (CQA) 28-02-20
Action Plan will be designed & completed by CQA before 28-
02-20 (Responsibility Assigned to Mr. Sandeep Bakshi (QA Mr. Sachin Tyagi
17/22
 Sr. No. Comments / Recommendations
6. In the personnel dressing rooms the visualization of such
procedures is used. It is also recommended to place
visualization of dressing procedures not only for the personnel of
the enterprise, but also for visitors, since different clothes and
different dressing procedures are used. It is also recommended
to supplement the visualization of exit procedures from
production facilities, since the correct implementation of these
procedures is also important. It should also be noted that in most
locks for personnel dressing there are no sinks and devices for
hand-washing.
7. When preparing technological process validation protocols, it is
recommended to pay attention to the study and establishment of
critical process parameters (CPP), critical quality attributes
(CQA) and acceptance criteria. It is good practice of
development of such parameters to conduct a risk analysis
before developing a process validation protocol (EU GMP Annex
15: cl. 5.21).
It is expected that the Process Validation Protocols will contain
at least all the sections specified in clause 5.22 of Annex 15 of
EU GMP.
Report // Pinnacle Life science Pvt Ltd. // India // 10.2019
Action Plan : Responsibility TCD
Head), . (WH Head)
As guided by the Inspection Expert, the recommended Mr. Ashok Chawla 28-02-20
updations will be incorporated in the system & SOP will be (HR Head)
prepared & implemented for the same. SOP preparation w.r.t 28-02-20
visitors will be done before 30-01-20 (By HR Dept.) under Mr. Harish Senger
Quality Head’s Guidance. Implementation of SOP & completion (PR Head). 28-02-20
of display / visualization as per SOP will be completed before
28-02-20 (Responsibility Assigned to Mr. Ashok Chawla (HR Mr. Sachin Tyagi
Head). (WH Head) &
Existing Entry Exit SOP for Production Block for own
employees (site personnel) will be revised for recommended Mr. Manoj Sharma
upgradation (By PR Incharge). Implementation of revised SOP (QC Head).
& completion of display / visualization as per revised SOP will
be completed before 28-02-20 (Responsibility Assigned to Mr.
Harish Senger (PR Head).
Similarly Warehouse area change rooms & QC Lab change
room procedure (SOP) will be updated respectively by QC &
WH Dept. under site Quality Head’s guidance. Implementation
of revised SOP & completion of display / visualization as per
revised SOP will be completed before 28-02-20 (Responsibility
Assigned to Mr. Sachin Tyagi (WH Head) & Mr. Manoj Sharma
(QC Head).
As guided by the Inspection Expert & reference guidance Mr. Sandeep Bakshi 30-01-20
document (EU GMP Annex 15), it is decided to revise the (QA Head) &
existing SOP governing Process Validation Activity at site. The
SOP will be revised to incorporate all the sections specified in Mr. Harish Senger
the reference document, inspector’s guidance, identification of (PR Head) &
CPP, CQA through risk assessment & acceptance criteria for
the same. Mr. Manoj Sharma
Based on the revised SOP, the Protocol for the Process (QC Head).
Validation of each formulation will also be revised & further
validation activity will be carried out as per revised SOP &
Protocols. The recommended updations will be incorporated in
the SOP before 30-01-20 & Validation Activity will be carried
out inline with the revised SOP. 30-01-20 (Responsibility
Assigned to Mr. Sandeep Bakshi (QA Head) & Mr. Harish
Senger (PR Head) & Mr. Manoj Sharma (QC Head).
18/22
 Sr. No. Comments / Recommendations
8. The positions that can fulfil the duties of the Qualified Person
(QP) of the enterprise in case of its absence (vacation, business
trip etc.) should be clearly defined. Their job description should
state that they can be appointed to perform such duties. The
Qualified Person of the enterprise can conduct an additional
assessment and release of the batch, since only duties can be
delegated, but not responsibility, i.e. in any case, the QP should
and will be responsible for the batch release.
9. Attention should be paid to the risk of cross-contamination in the
production of the antibiotic Azithromycin. The joint production of
antibiotics and non-antibiotics will attract the attention of
inspectors. It is possible, to demonstrate intentions to minimize
the risk of cross-contamination, to prepare a risk assessment
document in which one should assess all possible sources of
contamination and provide measures to minimize such risks.
10. Sampling of finished products should ensure the
representativeness of the sample taken, often this is ensured by
sampling at the beginning, middle and end of the packaging
process. This approach should be clearly defined and described
in the relevant SOPs, and the fact of sampling should be
recorded (for example, in the batch production protocol).
11. Workplaces should have recorded copies of written
procedures – SOPs or extracts from them. These SOPs or
extracts were not always at workplaces, for example, near the
autoclave located in the microbiological laboratory and in which
sterilization of nutrient media takes place, there is no written
procedure or extract from SOPs or visualization of autoclave
loading. This practice may be the reason for inconsistency
during the official inspection with the wording that there are no
instructions at the operator’s workplace, etc.
Report // Pinnacle Life science Pvt Ltd. // India // 10.2019
Action Plan : Responsibility TCD
As guided by the Inspection Expert, the JD of QP & his/her Mr. Sandeep Bakshi 28-02-20.
designee will be made inline with the EU GMP Guidance (QA Head).
Document recommendations & requirements. A defined policy
will be implemented detailing details of duties governed by QP.
Also the delegation of QP’s duties to his designee in any case
will be clearly detailed in the policy & same will be followed
strictly.
Accordingly the SOP governing the procedure of assignment of
duties & JD preparation will also be revised to update the
recommended instructions. The entire activity will be completed
& implemented before 28-02-20. (Responsibility Assigned to
Mr. Sandeep Bakshi (QA Head).
As guided by the Inspection Expert, a detailed risk assessment Mr. Sandeep Bakshi 30-03-20
will be carried out for the worst case scenario & possibilities of
Azithromycin cross contamination and available control
measures & identification of requirements of additional control
measures based on identified risks.
The activity will be completed before 30-03-20. (Responsibility
Assigned to Mr. Sandeep Bakshi (QA Head).
As guided by the Inspection Expert, the existing system Mr. Sandeep Bakshi 30-01-20
reviewed & revealed that the SOP is available for sampling of (QA Head).
Inprocess & Finished Goods is available but detailed procedure
to collect the samples as initial middle & end plan is not
described in the SOP.
However the procedure & sampling activity record in BNR/BPR
is with provision of initial middle & end of the process of any
stage. Thus SOP will be revised to incorporate detailed
procedural instructions for sampling of Inprocess & Finished
Products with Initial middle & end stage of the process stage
(from which the representative sample to be collected). BMR &
BPR shall also be updated with the incorporation of revised
SOP reference accordingly.
The SOP revision & updation will be completed before 30-01-
20. (Responsibility Assigned to Mr. Sandeep Bakshi (QA
Head).
Based on the observation & recommendations by inspection Mr. Sandeep Bakshi 30-03-20.
expert, it is decided to implement the policy to maintain copies (QA Head),
of standard procedures in the workplace near to the workstation Mr. Harish Senger
of equipment / instruments along with the recorded logs for the (PR Head),
same. In addition to this the policy will also be incorporated with Mr. Manoj Sharma
procedure to incorporate visualization pictorial extracts of the (QC Head),
procedure in the respective SOP & same will be displayed at Mr. Sachin Tyagi
workplace near to work station / equipment / instruments to (WH Head),
achieve lifecycle consistency at workplace. Mr. Amit Kumar (MN
19/22
 Sr. No. Comments / Recommendations Action Plan : Responsibility TCD
Along with the preparation & updation of policies, training will Head),
be imparted to all concerned personnel before implementation. Mr. Ashok Chawla
Entire activity will be completed before 30-03-20. (HR Head).
(Responsibility Assigned to Mr. Sandeep Bakshi (QA Head),
Mr. Harish Senger (PR Head), Mr. Manoj Sharma (QC Head),
Mr. Sachin Tyagi (WH Head), Mr. Amit Kumar (MN Head), Mr.
Ashok Chawla (HR Head).
12. One of the common inspection practices is to verify Based on the observation & recommendations by inspection Mr. Sandeep Bakshi 30-03-20
validation/qualification results with written procedures used in expert, it is decided to review each & every Qualification & (QA Head),
the routine process. For instance, autoclave sterilization Validation SOP, Protocols & Reports for its completeness & Mr. Harish Senger
validation – the loading methods described in SOPs must be based on the review outputs, required updations, revisions will (PR Head),
validated; based on the results of a study of the temperature be done to upgrade the system compliant with current Mr. Manoj Sharma
distribution in the warehouses for raw materials and finished regulatory requirements & expectations. (QC Head),
products storage, places for routine temperature monitoring are A review task force will be deputed for the proposed Action Mr. Sachin Tyagi
selected; sterilization modes in the tunnel sterilizer (temperature, Plan. The task force will be comprised of SME from CFT (WH Head),
conveyor belt speed) should coincide or have reasonable departments like QC, QA, MN, PR, IT, HR. The entire activity Mr. Amit Kumar (MN
differences; etc. will be completed before 30-03-20 (Responsibility Assigned to Head),
Mr. Sandeep Bakshi (QA Head), Mr. Harish Senger (PR Head), Mr. Ashok Chawla
Mr. Manoj Sharma (QC Head), Mr. Sachin Tyagi (WH Head), (HR Head).
Mr. Amit Kumar (MN Head), Mr. Ashok Chawla (HR Head).
13. Measures to eliminate identified deviations during the self- Based on the guidance document (Chapter 9 Self Inspection) & Mr. Sandeep Bakshi 30-12-19
inspection should be developed by the responsible personnel of recommendations given by inspection expert, it is decided to (QA Head),
the structural unit in which the self-inspection was carried out. revise the existing SOP for Self Inspection Activity to Mr. Harish Senger
incorporate the procedure & detailed format for recording the (PR Head),
observations & inspection report preparation. Compliance Mr. Manoj Sharma
report format & verification of conformity & compliance CAPA (QC Head),
implementation & closure review report with certificate. Entire Mr. Sachin Tyagi
activity will be completed & implemented before 30-12-19. (WH Head),
(Responsibility Assigned to Mr. Sandeep Bakshi (QA Head), Mr. Amit Kumar (MN
Mr. Harish Senger (PR Head), Mr. Manoj Sharma (QC Head), Head),
Mr. Sachin Tyagi (WH Head), Mr. Amit Kumar (MN Head), Mr. Mr. Ashok Chawla
Ashok Chawla (HR Head) i.e Entire SI team under Quality (HR Head)
Heads Guidance
14. The list of documents of the enterprise quality system is Based on the guidance document (Chapter 4 Documentation) & Mr. Sandeep Bakshi 30-12-19.
recommended to be drawn up in the form of a schedule that recommendations given by inspection expert, it is decided to (QA Head).
would reflect the review date and record the result (whether it revise the existing SOP for Documents & Data Control to
was reviewed or not, by whom, and when). incorporate the provision to mention the effective date, next
review date and review Status whether it is reviewed on time or
not, by whom and when).
The revised SOP will be implemented before 30-12-19.
(Responsibility Assigned to Mr. Sandeep Bakshi (QA Head).
15. Not all personal and material locks have a system for blocking Based on the guidance document (Chapter 3 - Premise and Mr. Robin Lukose 30-01-20
the simultaneous opening of two doors of a lock or a warning Equipment) & recommendations given by inspection expert, it is
system for simultaneous opening of a lock. For example, a lock decided to install interlocking systems with Alarm in all Mr. Anil Kumar

Report // Pinnacle Life science Pvt Ltd. // India // 10.2019 20/22

 Sr. No. Comments / Recommendations Action Plan : Responsibility TCD
in a raw material sampling area. personnel & material airlocks at entire facility. Baliyan (GM
The installation work will be completed before 30-01-20. Operations)
(Responsibility Assigned to Mr. Robin Lukose under guidance
of Mr. Anil Kumar Baliyan (GM Operations) & Mr. Sandeep Mr. Sandeep Bakshi
Bakshi (QA Head). (QA Head).
16. For production facilities, warehouse premises and quality control Based on the guidance document (Chapter 3 - Premise and Mr. Robin Lukose 30-01-20
rooms, strict access control should be in place to prevent Equipment) & recommendations given by inspection expert, it is
passage of personnel who do not work in these rooms. decided to install biometric access controls systems in all Mr. Anil Kumar
sections / cubicles / areas at entire facility to restrict the Baliyan (GM
unauthorized entry in any of the area. Operations)
The installation work will be completed before 30-01-20.
(Responsibility Assigned to Mr. Robin Lukose under guidance Mr. Sandeep Bakshi
of Mr. Anil Kumar Baliyan (GM Operations) & Mr. Sandeep (QA Head)
Bakshi (QA Head)
17. In some production facilities, Major damage to the floor, walls, Based on the observations, the repair & maintenance work of Mr. Robin Lukose 28-02-19
and ceiling of other structural elements is observed. For entire flooring & damages to entire facility controlled & under guidance of
example, Major damage to the floor was observed in the classified areas has been initiated in phased manner & Mr. Anil Kumar
granulation room, and the floor was also severely damaged in expected to be completed before 28-02-19. Baliyan (GM
the washing room. Inspector's expectations – all elements of Further the SOP for Building / Facility Maintenance will be Operations) & Mr.
clean rooms should be even and smooth to ensure proper revised to incorporation of Building management system Team Sandeep Bakshi (QA
cleaning. for compliance of the SOP & scheduled facility preventive Head).
maintenance program will be implemented strictly. BMS team
will be formed by GM Operations in coordination with Site QA
Head by selecting the SMEs from individual departments
(CFT). The compliance of the same will be ensured by BMS
Team under BMS Incharge Site Quality Function Head.
18. Major accumulation of dirt was observed at the door closures. All Based on the observations & recommendations & guidance Mr. Harish Senger 30-01-20
elements that are in clean rooms should be carefully cleaned. provided by the inspection expert, the respective area & (PR Head), Mr.
The relevant procedures should list the items to be cleaned: equipment cleaning SOP are taken under revision to Manoj Sharma (QC
watches, fire extinguishers, video cameras, etc. incorporate the grey /hidden area & equipment list of items to Head), Mr. Sachin
be cleaned like clocks, watches, hygrometers, Table Top, cross Tyagi (WH Head),
over bench, Garment Cabinets, VTS Closures, Pallets, SS Mr. Amit Kumar (MN
Trolley, SS Material Transfer cabinets, rejection bins, Head), Mr. Ashok
accessories, cutters, hammers, SS Bins & Bowls, fire Chawla (HR Head),
extinguishers, video cameras etc. New SOP will be prepared Mr. Sandeep Bakshi
along with Checklists for the items which are available in (QA Head)
classified & controlled areas but not covered or governed under
any SOP. Entire activity will be completed before 30-01-20.

Report // Pinnacle Life science Pvt Ltd. // India // 10.2019 21/22

 Sr. No. Comments / Recommendations Action Plan : Responsibility TCD
19. Attention should be paid to one of the processes of packing On review of activity & documents, it is observed that the SOP Mr. Harish Senger 30-01-20
tablets and capsules. During the stop of the packaging machine, for Packing of Products will be revised to include the checklist (PR Head), Mr.
part of the already packaged tablets or capsules is exposed to with checkpoints to discard the part of the already packaged Sandeep Bakshi (QA
high temperature from the sealing plate (temperature can be tablets or capsules is exposed to high temperature from the Head).
2000С and higher). It is normal practice to discard blisters that sealing plate in case of machine stop.
have been exposed to excessive temperature. Such a system
should work in a routine, and its performance should be Provision to record the same in BPR & verification by
confirmed during validation. concerned IPQA personnel will be incorporated. The entire
activity will be completed before 30-01-20
20. The personnel training procedures should have clear and Based on the guidance provided by the inspection expert, it is Mr. Harish Senger 28-02-20.
detailed instructions on the hand washing procedure and the decided to provide hand washing facility in the primary (PR Head), Mr.
hand disinfection procedure. These may be separate personnel airlocks/change rooms for hand washing & SOP for Manoj Sharma (QC
procedures; it is possible to refer to them in the procedures for the same incorporate the procedure of hand washing & Head), Mr. Sachin
personnel training. It is recommended to place visualization of disinfection procedure along with pictorial displays & training to Tyagi (WH Head),
washing and disinfection procedures for hands in the personnel all concerned as basic requirement of personnel hygiene. Mr. Amit Kumar (MN
locks. The personnel training should also include visualization of Head), Mr. Ashok
the dressing procedure (for entry and exit) for both employees The Pictorials displays along with the procedure to follow the Chawla (HR Head)
and guests, the corresponding images should be placed in the same will be incorporated in the SOP & training modules & under technical
locks. All photographs should contain links to the procedure, reference form number will be allocated to ensure guidance of Site
which provides this Action Plan when changing clothes synchronization of Displays with respective SOP. Entire activity Quality Head)
will be completed before 28-02-20

.Conclusion: According to the results of the audit conducted, it can be stated that the quality management system and the level of technical
equipment of the enterprise cannot be assessed as one that complies with the principles of Good Manufacturing Practice without
proper and complete elimination of identified deviations.
Based on the results of this report, the enterprise is invited to develop a corrective and preventive Action Plan, which, in turn, is
proposed to be evaluated for its completeness and correctness.

Ref : https://europa.eu/halth/documnts/eudra_en

Report // Pinnacle Life science Pvt Ltd. // India // 10.2019 22/22