Finalized Draft of Intas Audit Compliance Report 05-12-20

PINNACLE LIFE SCIENCE PVT. LTD.
Page 1 of 14
Khasra No. 1328-1330, Village Manpura, Tehsil Baddi, Distt. Solan (H.P) 174101
M/s INTAS PHARMACEUTICALS LTD. AUDIT COMPLIANCE REPORT
Manufacturer M/s Pinnacle Life Science Pvt. Ltd.

Contact Address Khasra No. 1328-1330, Village - Manpura, Tehsil - Baddi, District Solan, Himachal Pradesh-174101
Date of Audit 06-11-2020 & 07-11-2020
Purview of Audit To evaluate the compliance of manufacturing facility in accordance with GMP.
Mr. Ritesh Thapliyal,Sr. Executive CQA
Auditor
Mr. Ravikant Mishra,Sr. Executive CQA
Mr. Anil Kumar ,(GM Operations), M/s. Pinnacle Life Science Pvt Ltd, Baddi
Persons present during audit Mr. Saleem Jawed , (Quality Head), M/s. Pinnacle Life Science Pvt Ltd, Baddi
Dr Deepak K Thakur (Manager QA) M/s. Pinnacle Life Science Pvt Ltd, Baddi
Sr. Responsibi Target Date
Audit Observations Recommendation Auditee Response
No. lity Responsibility
1. During Audit round in RM Sachin Procedural 1.1 On investigation, the records of the NA
warehouse following Tyagi controls shall be consignment is checked & the physical quantity Mr. Sachin Tyagi,
discrepancies was observed: established for of the material in the bag found correct & the Warehouse Head
1.1) RM Metronidazole B.No. &
MTZ/0081270 loose bag Handling, labeling AR Number of the material also found correct.
Mr. Gurpreet Singh Khalsa,
stored in approved material and storage of Further on opening of the bag, it is revealed
IPQA Head.
store without loose Bin card. RM. that the bag bin card is tied on the inner
1.2) RM Glycerol monoacetate secondary polybag. The quantity mentioned on
stored on approved material the bin card also found correct. Now the bin
store without any label.
1.3) Retest date of Mometasone card has been affixed on outermost bag & the
Furoate USP B.No. MLMFT- concerned personnel (from Warehouse &
010118 was 07-03-2019 but IPQA) have been instructed & retrained for
not retested on due date. Good Labeling Practices inline with SOP.
1.4) The approved vendor list is Photograph of the bin card affixed on inner
not updated i.e. as per
approved vendor list the raw secondary bag is attached as Annexure-I
material Azithromycin IP the Copy of training record is attached as
approved Vendor is Shangai Annexure-II
shydec but the batch number
This is confidential information of Pinnacle Life Science Pvt. Ltd., any unauthorized access or use or distribution without written consent from M/s Pinnacle Life Science will be considered offence
Page 2 of 14

AZH- 200913 of azithromycin 1.2 Based on the observations, detailed
IP procured from another investigation carried out. On review of the
vendor which is not material, it is found that the labeling tag was
mentioned in approved
vendor list. removed from the outer most bag during
handling & the concerned warehouse person
tied the same on inner secondary bag of the
material. Further to ensure the same, the
consignment is tracked with GRN, Inventory
Records, QC Analysis records & ERP data &
all the records confirmed the material
identification & physical quantity. Further to
assure 100% identity of the material, the
sample of the material sent to QC for
identification & %age purity by FTIR. The
results of FTIR analysis confirmed that the
material is Glycerol monoacetate & complying
with the standard specifications.
Further the entire materials stored in the
warehouse are also verified by Warehouse
personnel in presence of IPQA for the similar
discrepancies in labeling. All the materials
found with adequate labeling. Now the
concerned personnel (from Warehouse &
IPQA) have been instructed & retrained for
Good Labeling Practices inline with SOP.
Photograph of label tied on inner secondary
bag is attached as Annexure-III
Copy of Training record is attached as
Annexure-II
Page 3 of 14

Copy of FTIR analysis record is attached as
Annexure-IV
1.3 On investigation & discussion with the
concerned personnel, it is revealed that the
Mometasone Furoate USP B.No. MLMFT-
010118 is not in use & there wasn’t any plan
for the same after Aug. 2018 & currently also
there is no plan for the products in which the
material to be consumed. The material is kept
as non moving stock & as per the SOP, in case
of non moving stock, the materials are retested
before use (production plan) only. But the
concerned person failed to explain the same to
auditors during audit. Now the concerned
personnel have been retrained & counseled to
reply to the auditors inline with standard
practices followed as per the implemented
SOP.
Copy of the SOP is attached as Annexure-V
Copy of Training record is attached as
Annexure-II.
1.4 On detailed investigation, review of records
and discussion with concerned personnel, it is
revealed that during Covid 19 pandemic
outrage in the country as well as in China, the
supply of Azithromycin API got hampered.
Meanwhile the market demand of the
Page 4 of 14

Azithromycin tablets increased suddenly as
Covid 19 medication included Azithromycin
tablets too. Hence the existing approved
vendors couldn't supplied the required quantity
of the Azithromycin. So considering the worst
pandemic outrage, we have procured the
Azithromycin from new source as conditional
approval under deviation. However all the
prerequisites except physical site audit have
been fulfilled prior to receive the material. The
material is tested for the standard
pharmacopeial parameters and approved after
completion and compliance of the standard
pharmacopeial parameters. Further it is
decided that the initial batch (in which the
material will be used from unapproved /
conditionally accepted source) will be charged
on stability study.
Copy of deviation form is attached as
Annexure-VI.
Copy of analysis record of the material
(Azithromycin IP batch number AZH- 200913)
is attached as Annexure-VII.
2. The vendor having a common Sachin Incident / Based on the audit observations the detailed TCD : NA
Page 5 of 14

sampling and dispensing area for Tyagi deviation to be investigation is carried out it is revealed that Mr. Sachin Tyagi,
liquid section but at the time of initiated, the weighing balance of the area was under Warehouse Head
inspection it was observed there investigation to be breakdown maintenance & the logs were in &
Mr. Gurpreet Singh Khalsa,
was no weighing balance available performed along warehouse office for verification by Warehouse IPQA Head.
and no dispensing and sampling with root cause Incharge & IPQA Incharge to check the daily
records found for the same. and appropriate verification, calibration & review & checking of
CAPA to be dispensing activity occupancy of the balance to
implemented assess the root cause of breakdown. But the
along-with impact concerned person couldn’t explained the same
assessement. to the auditors due to audit hesitation and got
audit observation. Now the concerned
personnel have been counseled and motivated
to reply to the auditors without any hesitation or
audit phobia. Also the reviewer & verifying
personnel are instructed to review & verify the
logs in the respective area instead of taking the
logs to the office area.
Copy of the area activities logbook is attached
as Annexure-VIII.
Photograph of weighing balance is attached as
Annexure-IX.
3. During visit in manufacturing area Harish Incident/deviation 3.1 The investigation is carried out in detail and
following discrepancy was Kumar shall be initiated, during investigation it is found that the 31-01-21 for new
observed investigation shall hygrometer was malfunctioning and was Hygrometer installation.
3.1) Common area is dedicated
be performed showing the results beyond the limits. The
Page 6 of 14

to uncoated and coated along with root malfunctioning is confirmed with cross
tablets quarantine which is cause and CAPA verification of the area temperature & %RH
segregated by separate to be with calibrated data logger & the results found
racks while checking the
memory of digital hygrometer implemented. well within standard limits. Also the
of that area (PT/DTH-022) Impact of malfunctioning hygrometer is verified with
the maximum temperature temperature calibrated data logger & confirmed the
found 31.90C and humidity needs to be malfunctioning of the Hygrometer. On further
observed 94% although the assessed on verification of the area on very same day with
mentioned limit of Temp. is
NMT 27 and RH is NMT 55. available the data logger, the area temperature and
3.2) The punch inspection format consignment %RH observed well within the standard limits
does not cover the scope of Procedural i.e. 24.3oC temperature and %RH as 47%. Mr. Harish Senger,
checking Concentricity controls shall be Moreover the out of limit results shown by the Production Head.
parameters established for hygrometer are practically not possible,
3.3) Magnehelic differential Mr. Gurpreet Singh Khalsa,
pressure gauge of first floor inspection of because the %RH shown by the hygrometer as IPQA Head.
granulation entry not in punches. Kindly much as 94% was not evident in the area Mr. Robin Lukose,
working condition. share revised during audit also and there was no discomfort Projects Head.
SOP.Provide TCD experienced in the area. Now the hygrometer Mr. Saleem Javed,
Incident/deviation has been rectified and re calibration has been Quality Head
shall be initiated, done. Additionally we have done the thermal
investigation shall and %RH mapping of the area to ensure the
be performed area is under control with the existing control
along with root measures available & implemented at site. The
cause and CAPA mapping data found well within the compliance.
to be Based on the observation & malfunctioning of
implemented. the current hygrometer, it is decided to replace
the existing hygrometers with latest compact
Neutron hygrometers for better reliability &
assurance. The proposal to procure these new
Page 7 of 14

hygrometers has been approved by the
Management & the procurement process has
been initiated. Demo has also been given by
the vendor at our site & Quality Unit &
concerned user departments found these
better than the existing ones. The replacement
of hygrometers will be done on or before 31-
01-21. Further the recording of Minimum &
Maximum excursions throughout the period of
previous monitoring / recording & current
monitoring / recording has been included in the
procedure & record of the same is being
maintained in logbook.
Copy of thermal mapping data of the area is
attached as Annexure-X
Copy of the monitoring record logbook is
attached as Annexure-XI
3.2 As guided by the auditors, the SOP for
Punch Inspection has been taken under
revision to incorporate the procedural
instructions to check Concentricity parameters
& recording format will also be revised
accordingly to provide the provision to record
the same in format. The revised SOP & Form
will be implemented on or before 10-12-20.
3.3 On detailed investigation, review of records
& discussion with the concerned personnel
from Production & IPQA, it is revealed that
Page 8 of 14

during audit, the area was under cleaning &
AHU was switched off, due to which the ∆P
monitoring gauge was not responding against
the door opening. But the concerned person
didn’t explained the same to the auditor & got
the audit observation. Now the concerned
personnel have been counseled to reply to the
auditors without any hesitation or audit phobia.
A video clip showing the functioning of the
Magnehelic gauge is attached as Annexure-
XII
4. While reviewing the BMR of Gurpreet Training shall be Based on the observation, the detailed TCD : NA
Cypotin plus syrup B.No. ML-034 provided to all investigation carried out & it is observed that Mr. Harish Senger,
it was observed dispensing label concerned the BMR copy of the label is missing from the Production Head.
of Mix fruit flavor missing in
attached dispensed label sheet. regarding GMP & BMR docket. Thus to confirm the material input Mr. Sachin Tyagi,
GDP. in the batch, the issuance record from the Warehouse Head
dispensing is checked & found records Mr. Gurpreet Singh Khalsa,
showing the dispensing of the flavor in required IPQA Head.
quantity. Same record is tallied with ERP
record & found correct. Further the BMR is
reviewed for verification of materials at
manufacturing stage & found correct. Also the
dispensing & verification of materials has been
monitored & confirmed by IPQA. Further the
batch quantity & yield confirmed that the
standard quantities of all the materials have
been included in batch as per standard batch
formula / BOM. In addition to this the control
Page 9 of 14

sample of the batch is checked for required
flavor & found satisfactory. Also the control
samples of the batch is compared with the
other batches of the product & found similar
w.r.t. flavor. The quantity of the flavor in stock
is also checked w.r.t. the batches
manufactured & found satisfactory. Hence with
the above investigation & verification of the
records, it is confirmed that the flavor quantity
is added in the batch, only the dispensing label
is missing, which might be misplaced during
processing or review. Now to overcome such
discrepancies, we have already implemented
the control measures which includes,
verification of the dispensing labels by
production as well as IPQA during each &
every stage of manufacturing & packaging. The
check point to verify the labels is also included
in line clearance checklist & BMR/BPR review
checklist. All the concerned personnel have
been trained & instructed to follow the same.
Copy of the LC checklist is attached as
Annexure-XIII
Copy of BMR / BPR review checklist is
attached as Annexure-XIV
Copy of training record is attached as
Annexure-XV.
Page 10 of 14

5. While reviewing the Volumetric Manoj 5.1 Based on the audit observations & as
solution preparation record in sir TCD: NA
guided by the auditors, the concerned SOP has
QC following discrepancies was been revised to incorporate the procedural
observed: Mr. Manoj Sharma
5.1) Primary standard name, instructions to record the Name of the primary QC Head
B.no. and make not standard, Batch Number, Make in the
Mr. Ambuj Kumar
mentioned in preparation Procedural preparation as well as consumption log. The
GLP Head
record. controls shall be format for the logbook has also been revised to
5.2) Primary standard vial label Mr. Saleem Javed
established for include columns to record the Name of the
not having quantity of Quality Head
standard. maintained primary standard, Batch Number, Make of
consumption Primary standard along with other details. The Ms. Sweta Agnihotri
5.3) Primary standard consumption
AQA Incharge
record maintained on record of primary revised SOP & format has been implemented
uncontrolled format. standard . Kindly after satisfactory training to all concerned
revised personnel from QC & AQA.
SOP.Provide TCD Copy of revised SOP & Log Format is attached
as Annexure-XVI
Copy of the training record is attached as
Annexure-XVII
5.2 Based on the audit observations & as
guided by the auditors, the concerned SOP has
been revised to incorporate the procedural
instructions to mention the Quantity of the
primary standard in the vial label. The format
for the label has also been revised to include
columns to record the quantity of the primary
standard. The revised SOP & label format has
been implemented after training to all
concerned personnel from QC & AQA.
Copy of revised SOP & Log Format is attached
Page 11 of 14

as Annexure-XVIII
Annexure-XIX
5.3 Based on the audit observations, the
concerned SOP has been revised to
incorporate the procedural instructions to use
the consumption record format as pre-printed
bounded logbook in standard format. The
format for the logbook has also been revised to
include the standard Header Footer contents
like Firm Name, Document Number, Document
Title, Format Number etc. The revised SOP &
label format are made effective & logbooks are
ordered for printing. The bounded logbooks will
be made available before 20-12-20 & be
implemented from 01-01-21.
Copy of revised SOP & Logbook Format is
attached as Annexure-XX
Annexure-XXI
6. Fire extinguisher in RM store Anil Sir Procedural Based on the audit observations & guidance TCD : NA
HR/FEX-010 & HR/FEX-033 not (HR) controls shall be provided by the auditors, the investigation is Mr. Anil Dogra
having any label of filling and established for carried out & on investigation, it is observed Head, HR
refilling date. maintained filling that the labeling on the cylinders was done by Ms. Pooja Rani
and refilling date sticking the sticker labels on cylinders. But as Asst. Head, HR
record of Fire per the HR person, the sticker labels got
Mr. Sarabjeet Singh
extinguisher . spoiled & removed during regular cleaning. HR Supervisor
Page 12 of 14

Kindly revised Further the on-books record of the cylinders for
SOP.Provide TCD filling, refilling, re-certification dates is checked
& found available & adequate. The Gate entry
records & PO records also confirmed the
same. Thus with the above investigation it is
confirmed that the FE Cylinders are within
validity period. Further to avoid such
discrepancies, the labeling of the FE Cylinders
is done by affixing a Plastic Sheet as base with
cable tie on cylinders tag / label hook &
respective labels are pasted on the plastic
sheet base & transparent lamination tape is
pasted on the labels as protective covering to
avoid the removal of labels during cleaning &
handling. Further the concerned HR supervisor
is instructed to verify the same during cleaning
of the FE Cylinder.
Photograph of labeling is attached as
Annexure-XXII
Annexure-XXIII.
7. Megnehelic differential pressure Harish Sir Incident/deviation As detailed in compliance reply of point number Mr. Harish Senger,
gauges of first floor granulation shall be initiated, 3.3, the detailed investigation, review of Production Head.
entry not in working condition investigation shall records & discussion with the concerned Mr. Gurpreet Singh Khalsa,
IPQA Head.
be performed personnel from Production & IPQA, revealed
along with root that during audit, the area was under cleaning Mr. Robin Lukose,
Projects Head.
cause and CAPA & AHU was switched off, due to which the ∆P
to be monitoring gauge was not responding against Mr. Saleem Javed,
Page 13 of 14

implemented. the door opening. But the concerned person Quality Head
didn’t explained the same to the auditor & got
the audit observation. Now the concerned
personnel have been counseled to reply to the
auditors without any hesitation or audit phobia.
A video clip showing the functioning of the
Magnehelic gauge is attached as Annexure-
XII
8. In liquid manufacturing area the Harish Sir As guided by the auditors, the dedicated SS TCD : NA
dedicated SS pipes was used for pipes being used in the liquid manufacturing Mr. Harish Senger,
transferring the material but ID area for transferring the materials are coded Production Head.
number is not given to the pipes.
with ID numbers by engraving the ID number Mr. Gurpreet Singh Khalsa,
on both ends of the pipes. IPQA Head.
Photograph of ID numbering on SS pipes of Mr. Virendra Kumar,
liquid area is attached as Annexure-XXIV. Liquid Section Head.
9. While reviewing the AHU Punit Sir Based on the audit observations & as guided Dr. Deepak K Thakur
validation of second floor (QA) by the auditors, we have updated the protocol Manager QA
granulation it was observed Air for AHU validation as per current version of Mr. Puneet K Tiwari
velocity and filter integrity test
ISO 14644 Guidance document & incorporated Section Head, Qual & Val
perform annually. It should be
performed in every 6 months. the tests frequency as recommended in the Mr. Robin Lukose,
guidance document. Further validation testing Projects Head.
will be done as per revised protocol with
revised testing frequencies.
The copy of revised AHU Validation Protocol is
attached as Annexure-XXV.
With the above actions taken & CAPA Plans, we would like to assure the Esteemed Pharma Leader M/s Intas Pharmaceuticals Ltd., that as Pinnacle Life
Page 14 of 14

With the above compliance & CAPA Plan we assure our most valuable business associate that as Science Pvt. Ltd. we are ethically committed to ensure the
manufacturing & supply of best quality products to our clients. Also we are continuously working to improve our systems & practices. We have learned a lot
from your expert guidance. We also assure you that the commitments done in this compliance report will be strictly implemented & followed.
Particulars Prepared By Approved By Authorized By
Sign/Date
Name Ms. Jyoti Kannojia Dr. Deepak K Thakur Mr. Saleem Javed
Designation Executive QA (QMS) Manager QA Quality Head (QA/QC)

Finalized Draft of Intas Audit Compliance Report 05-12-20

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Finalized Draft of Intas Audit Compliance Report 05-12-20

Uploaded by

Copyright:

Available Formats

PINNACLE LIFE SCIENCE PVT. LTD.

M/s INTAS PHARMACEUTICALS LTD. AUDIT COMPLIANCE REPORT

Manufacturer M/s Pinnacle Life Science Pvt. Ltd.

M/s INTAS PHARMACEUTICALS LTD. AUDIT COMPLIANCE REPORT

M/s INTAS PHARMACEUTICALS LTD. AUDIT COMPLIANCE REPORT

M/s INTAS PHARMACEUTICALS LTD. AUDIT COMPLIANCE REPORT

M/s INTAS PHARMACEUTICALS LTD. AUDIT COMPLIANCE REPORT

M/s INTAS PHARMACEUTICALS LTD. AUDIT COMPLIANCE REPORT

M/s INTAS PHARMACEUTICALS LTD. AUDIT COMPLIANCE REPORT

M/s INTAS PHARMACEUTICALS LTD. AUDIT COMPLIANCE REPORT

M/s INTAS PHARMACEUTICALS LTD. AUDIT COMPLIANCE REPORT

M/s INTAS PHARMACEUTICALS LTD. AUDIT COMPLIANCE REPORT

M/s INTAS PHARMACEUTICALS LTD. AUDIT COMPLIANCE REPORT

M/s INTAS PHARMACEUTICALS LTD. AUDIT COMPLIANCE REPORT

M/s INTAS PHARMACEUTICALS LTD. AUDIT COMPLIANCE REPORT

M/s INTAS PHARMACEUTICALS LTD. AUDIT COMPLIANCE REPORT

Particulars Prepared By Approved By Authorized By

You might also like