Report 10.2019 - Eng

PINNACLE LIFE SCIENCE PVT. LTD.
Pg 1 of 19
Khasra No. 1328-1330, Village Manpura, Tehsil Baddi, Distt. Solan (H.P) 174101
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 1/19

Khasra No. 1328-1330, Village Manpura, Tehsil Baddi, Distt. Solan (H.P) Page 2 of 19
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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

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ІІ. DEVIATIONS IDENTIFIED
Deviations, observations, recommendations for elimination and/or comments:
GMP EC Qualification
Sr. No. Essence of deviation / violation Comments/Recommendations Compliance & CAPA Plan
clause of deviation TCD Responsibility
Submitted By M/s pinnacle Life science Pvt. Ltd.
1. Pharmaceutical quality system
1 1.10 The procedure for developing Minor This approach is not acceptable, since Based on the observation & recommendations, it is decided 31-12-19 Mr. Sandeep
annual product quality reviews quality reviews are developed not only for that the SOP governing “Annual Product Quality Review” shall Bakshi (QA
(PQR) provides for the inclusion of statistical evaluation of batches produced, be revised to incorporate the recommended procedural Head)
all batches produced if their number but also for assessing the validation / instructions to cover all the batches of the product
was less than ten, while it does not qualification status, review of deviations, manufactured throughout the calender year. Even if less than
indicate how many batches should review of changes in the product registration three batches or no batch manufactured in the calender year,
be included in the review if the total status, etc. then also the APQR will be prepared for the batches produced
number of batches produced is Moreover, if less than three batches were in the previous 2 years (depending on the total number of
more than ten. produced in the last year it is recommended batches produced over the period) to review all other QMS
If the total number of batches that the batches produced in the previous 2- aspects related to product like ongoing Stability Studies,
produced is less than three, a 3 years (depending on the total number of reproducibility of the process, Market complaints, CAPA
quality review is not developed. batches produced over the period, but not implementation review, vendor qualification review, change
Quality reviews do not display a more than 20-25 batches) be included in the controls, deviation, retention sample review status etc.
review of stability studies. assessment of stability and reproducibility of Revised SOP will be made effective on or before 31-12-19 &
No statistical methods are used to the process. Such an approach, if adopted, APQR for year 2019-20 onwards will be prepared as per
assess the stability and should be reflected in the SOP for revised SOP.
reproducibility of the process. 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.
2. Personnel
One of the elements of This element of the garment should be Based on the recommendations & guidance, it is decided to 15-01-20 Mr. Ashok
2 2.18 technological garment worn by Minor included in the procedures for preparing implement the denim booties instead of rubber shoes for the Chawla (HR
the personnel of the production sets of garments for work in production personnel working in the core controlled areas. The denim Head)
site is black rubber slippers. The premises. booties will be maintained serially in multiple sets for each
preparation of these slippers, person & entire activity will be governed through standard
before their use, is not described procedure. Entire arrangements will be done before 15-01-20.
in the relevant SOP.
3. Premises and equipment
3 3.3, 3.19 In the warehouse, the storage Major To store materials requiring different storage Based on the assessment report, it is decided that the materials 30-01-20 Mr. Sachin
temperature limit is set as “not more conditions, it is advisable to use different will be stored as per the recommended storage conditions Tyagi (WH
than 300С”. At the same time, rooms or set the temperature in the room (either provided by vendor/manufacturer or as per official Head)
materials that must be stored at a with the lowest value. compendium references). All the materials are under
temperature of “not more than assessment & verification of the recommended storage
250С”, as well as under “cool place” conditions. Based on the verification report, the required
conditions, are stored in the storage conditions will be maintained for materials storage. The
warehouse. entire activity will be completed before 30-01-20
4 3.2 In the warehouse for storing raw Minor Storing pallets on the floor is not Based on the inspection observations & guidance, it is decided 30-01-20 Mr. Sachin

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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.
materials, the first tier of pallets is recommended, as pallets will need to be to install racks system for storage of Materials to avoid direct Tyagi (WH
located on the floor. This method of moved for cleaning, which in turn can lead to palletization on the floor. The racks system will be so designed Head)
arranging pallets prevents the confusion. that cleaning will be smooth & accessible without physically
procedure for efficient cleaning of moving the stored materials. The racks system for RM storage
the floor surface of the warehouse. in Quarantine & undertest 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, As guided by the inspector, the non poisonous gum trap baits 20-12-19 Mr. Sachin
absence of rodents are used in the but not poisons for rodents. are installed inside the entry points of the Warehouse area. Tyagi (WH
warehouse. Location chart for the newly installed baits is under preparation Head)
& procedural instructions for the handling, checking & cleaning Mr. Ashok
of the same will be incorporated in the respective SOP for Chawla (HR
rodent control system. Head)
Required actions will be completed before 20-12-19
6 3.19, 5.10 Primary packaging materials (foil Major Primary packaging materials should be The observation is well taken immediately after inspection & the 30-12-19 Mr. Sachin
and film) are stored in a state that stored well-packed so as to prevent contact primary packing materials have been lined properly with Tyagi (WH
does not preclude their between the surfaces of the primary polybag and stored segregated to avoid the chances of mix-up Head)
contamination during storage. packaging materials and the surrounding & contamination. SOP shall also be revised to incorporate the
area of the warehouse. procedural instructions & PPM receiving checklist with
checkpoints to check the PPM for any damage or exposure
during receipt. Revised SOP will be implemented before 30-12-
19.
7 3.21 In warehouses for storing finished Minor For quarantine, it is desirable to have a Based on the inspection observation & recommendations, the 30-12-19 Mr. Sachin
products, a system for identifying separate, clearly defined zone. If a separate provision to store the Finished Goods segregated as per status Tyagi (WH
the status of finished products is not zone is not used, a system for identifying the like quarantine, undertest & approved (ready for dispatch). SOP Head)
used, namely, “Quarantine” and status of finished products should be used. for handling & dispatch of Finished Goods will be implemented
“Authorized for sale”. 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 before 30-
12-19
8 3.25 In the warehouse for storing printed Major Printed products should be treated very Based on the inspection observation & recommendations, the 20-12-19 Mr. Sachin
materials, a large number of open strictly and carefully. Storage should be SOP for handling of Printed Packaging Materials will be revised Tyagi (WH
boxes were observed, without streamlined; quantities of packaging to incorporate the Status Label (Loose Quantity) for systematic Head)
indicating the amount of printed materials should be strictly accounted. controls along with loose quantity inside the box. The PPM will
materials in the box. be stored under lock & key provisions with access control with
procedural controls & instructions to store PPM. Required
arrangements & implementations will be completed before 20-
12-19
9 3.18, 3.19 On the territory of the enterprise Minor The use of this room as a warehouse for the As guided by the expert it is planned to construct an airlock at 30-12-19 Mr. Sachin
there is another warehouse for storing finished products is not an example the entry point of outer FG Storage area & it is decided that the Tyagi (WH
storing finished products. This of good practice. It is recommended not to outer FG Storage area will be dedicated for the FG Goods Head)
warehouse is organized as a room use this room as a warehouse for finished which will be ready for dispatch after QP release. Moreover the
that directly contacts the street. products. area is equipped with air conditioning system for temperature
Entrance of personnel into this room controls. After construction of Air Lock, the thermal mapping of
is organized through single doors the area will be done & monitoring will be done based on the
without any dressing procedures, outcomes of the mapping. Concerned SOP will be revised &
the temperature in this room can updated accordingly. The entire activity will be completed
easily go beyond the established before 30-12-19.
limits, since during loading and

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unloading operations the doors will
be open.
10 3.2, 5.10 From the secondary packaging Major The direction of air movement should be Based on the observation, the DP issue has been resolved by 30-01-20 Mr. Robin
room, air enters the primary maintained from the primary packaging room maintaining the ACPH of respective AHU system. Now the air Lukose
packaging room (II Line). to the secondary packaging room to prevent flow is in proper direction. (Projects
There is no monitoring of air microbiological contamination of products. It is decided to install DP monitoring gauges between individual Head)
pressure drop between the primary primary packaging cubicle w.r.t secondary packaging hall to Mr. Harish
and secondary packaging rooms. monitor the DP across the primary cubicle & secondary Senger (PR
packaging hall. Respective SOP will be revised accordingly to Head)
incorporate the monitoring procedure & logging of the DP.
Additionally the Line clearance checklist & Inprocess monitoring
checklist of BPR will also be revised to incorporate the
checkpoint to verify the DP during initial line clearance activity &
at defined frequency throughout the packing operations. Entire
activity will be completed before 30-01-20.
11 3.34 The system of storage and Major The water circulation rate should be As guided by the expert, it is decided that the SOP for PWS Management Management
distribution of purified water has measured on return to the storage tank, as Tank vent filter replacement will be revised to incorporate the Decision Decision
Required
several disadvantages: an alternative indicator it is possible to use procedural instructions & frequency to check the vent filter Required
- the air filter is not checked after its the value of water flow (m3/hour). integrity before replacement to ensure that the vent filter was
replacement; The recommended storage temperature of well within required integrity throughout the installation period.
- the speed of water in the loop is water is no more than 250С. In addition to this, the PWS Tank vent filter assembly has been
not measured; replaced with EHFA (Electrical Heater Filter Assembly) which
- the storage temperature of purified keeps the vent filter above 800C, eliminating the chances of
water is equal to the ambient microbial growth at filter.
temperature. 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, it is decided that the PW storage
temperature will be maintained in two parts for the whore
calender year based on seasonal conditions. During Winter
period, the PW temperature will be maintained below 250C,
which will be normally maintained with seasonal environment
temperature which ranges between 70C to 180C. Other than
winter the PW temperature will be maintained above 600C,
which can be easily achieved with the available storage tank
which is jacketed type with the provision of steam heaters.
During non winter periods, the environmental temperature
ranges between 30 to 450C and tank & loop temperature also
increases accordingly, so the PW temperature can be
maintained above 600C easily with energy & resource efficient
process. The entire matter is under technical experts review &
will be freezed before 30-12-19 & finalized Action Plans will be
implemented before 30-03-20
12 3.34 To obtain compressed air, two Major Since compressed air has direct contact with As per observation & recommendations, the SOP & Protocol for 20-12-19 Mr. Robin
compressors are used, one of which the product, its quality is of great importance. compressed air monitoring will be revised & updated to 30-01-20 Lukose
in its design feature involves the use Air testing should be carried out periodically incorporate the periodic monitoring of the compressed air (Projects
of a significant amount of oil/grease, according to the indicators and methods coming in direct contact with product & equipment contact parts Head)

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which can enter the compressed air. described in ISO 8573. inline with ISO 8573 requirements. The proposed activities & Mr. Sandeep
The efficiency of the filter on the actions will be completed & implemented before 20-12-19 Bakshi (QA
compressed air supply line is not Further the integrity of the filters of supply line will also be Head)
checked. checked periodically & same shall be governed through
Pipes made of ordinary steel (not updated SOP. In addition to this it is decided that 0.1micron
stainless steel) are used for the filter at individual user points to eliminate the chances of any
compressed air transportation particulate contamination in the product & integrity of the same
system, which can create a risk of filters will be monitored on scheduled intervals. The entire
rust entering compressed air. activity will be completed before 30-01-20.
13 3.34, 3.38, For air treatment sets for granulation Minor These tests are mandatory. As guided by the expert, the protocol has been prepared for the 30-12-19 Mr. Sandeep
5.10 (FBD) and tablet coating equipment, filter integrity & intactness testing of FBD & Autocoater HEPA Bakshi (QA
HEPA filters are not checked for filters & same has been incorporated in Filter integrity testing Head)
integrity and tightness of the Schedule. The integrity testing is scheduled in last week of Mr. Robin
installation. December 2019. Reports for the same will be shared on Lukose
completion of the activity. (Engg. Head)
Copy of the Protocol along with schedule is attached as Mr. Harish
Annexure-13 (3.34, 3.38, 5.10) Senger (PR
Head)
14 3.19 The study of temperature Major Tests should be carried out in the hot and As recommended by the inspector & referring the Completed Mr. Sandeep
distribution (mapping) in the humid season. recommended guidance documents, the SOP for Temperature Bakshi (QA
premises of quarantine storage of Mapping has been revised to incorporate the required Head)
raw materials has not been procedural instructions & seasonal mapping schedule. Based Mr. Robin
performed. on the revised SOP, the protocol for mapping has been Lukose
prepared with incorporation of seasonal mapping plan of the (Engg. Head)
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
Annexure-14 (3.19)
15 3.1, 5.10 Instruments used for weighing raw Critical Preparation of instruments that have direct The observation has been taken under consideration 28-02-20 Mr. Robin
materials are washed and dried in contact with the product should be carried immediately after the inspection & as per Action Plan designed Lukose
an unclassified room; the supply of out in clean rooms or sterilized after for compliance, the washing area will be constructed outside (Engg. Head)
prepared and clean air is not preparation. the dispensing area in warehouse premises with adequate
provided for in this room. environmental & access controls. Area location & design with
execution plan has been prepared & sent for final approval from
Corporate Quality Expert & Hired GMP Experts. 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 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.
16 3.34 The chamber used for storing Major Qualification should be carried out in the As guided by the inspector & w.r.t. GMP requirements, the Completed Mr. Sandeep
samples for the further stability worst case scenario. qualification of the stability chambers has been done with Bakshi (QA
studies program was qualified maximum load & the qualification has been completed Head)
without being fully loaded with successfully. Reports of the qualification activity are attached
samples. as Annexure-16(3.34).
SOP & protocol for Stability chamber Qualification has been

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revised for scope, criteria & schedule for qualification.
Copy of revised SOP & Qualification Protocol along with
schedule are attached as Annexure-17(3.34).
5. Technological process
17 5.23 Technological process parameters Major All process and equipment operation Based on the inspection observation & guidance received from 30-12-19 Mr. Sandeep
that were confirmed during parameters must be confirmed during experts, the observed discrepancy is taken for impact Bakshi (QA
validation do not always correspond validation. Accordingly, all values must assessment & the product documents are reviewed for Head)
to the parameters used in routine coincide, the minimum and maximum values synchronization with validation report. BMR/BPR used for post
production. of the parameters must be checked, if such validation batches manufacturing couldn’t been revised w.r.t.
For example, for the medicinal a possibility is allowed during the routine validation report & the parameters were not freezed & further 4
product Ciprofloxacin 500, during production. more batches were manufactured with validation batch’s
validation the mixing time was Statistical methods such as ISO2859 should BMR/BPR without freezing the parametric limits. However it is
confirmed – 30 minutes, and in the be used to prepare a sampling plan during observed that the process of post validation batches was
routine production the duration of validation. carried out in line with the validated parameters but the values
the process was 25 minutes; tablet for parameters are handwritten instead of pre-printed fixed
press rotation rate during validation parametric limits. Now based on the investigation outcomes,
it is not known, and the rotation rate the SOP & Report form for Process validation has been taken
from 16 to 20 rpm is used in the under revision to incorporate the procedural instructions &
routine production; the speed of the conclusive details of final parameters & effective BMR/BPR with
packaging machine is not known incorporation of validated parameter’s limits.
both during the routine production In addition to this the SOP for preparation of BMR/BPR shall
and validation. 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.
Further more, 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 will be completed before 30-12-19
18 5.23 During sterilization validation in the Major Based on the observation, detailed investigation is carried out & 15-04-20 Mr. Manoj
autoclave, only biological indicators it is observed that the existing autoclave is an old model in Sharma (QC
were used without the use of which there is no provision of sensor insertion for temperature Head)
temperature measurement. 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.
20 5.20 When calculating the maximum Major When calculating medicinal product residues Based on the guidance & reference documents, It is decided to 30-12-19 Mr. Sandeep

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possible medicinal product residues one should use the Guideline on setting revise the Cleaning Validation Policy to incorporate the Bakshi (QA
on the equipment surface, the health based exposure limits for use in risk PDE/HBEL criteria for selection, assessment & calculation of & Head)
toxicological properties of the identification in the manufacture of different the maximum possible medicinal product residues on the
products were not used. medicinal products in shared facilities. equipment surface, allowable carryover w.r.t. toxicological 30-03-20
https://www.ema.europa.eu/en/documents/s properties of the products. The SOP & Protocol for Cleaning
cientific-guideline/guideline-setting-health- Validation has been taken under revision to incorporate the
based-exposure-limits-use-risk-identification- same. On revision of respective documents, the cleaning
manufacture-different_en.pdf validation activity will be carried out as per revised SOP &
Protocol. The revised documents will be made effective before
30-12-19 & the CV activity will be completed before 30-03-20.
21 3.6, 5.20 When determining the inaccessible Major For each unit of equipment, an assessment / As guided & recommended by the expert inspector the SOP & 30-12-19 Mr. Sandeep
places for cleaning equipment, no determination of places difficult to access for Protocol for Cleaning Validation has been taken under revision Bakshi (QA
studies were conducted, and the cleaning should be performed. One of the to incorporate the Riboflavin Test for identification of & Head)
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 proposed 30-03-20
equipment. in above point (Point No. 20). On revision of respective
documents, the cleaning validation 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 CV
activity will be completed before 30-03-20.
22 Annex 15 A procedure has not been Major Regardless of the method used to validate As per the guidance from inspector & reference from guidance 30-12-19 Mr. Sandeep
5.28 - 5.32 developed for conducting Ongoing the process, ongoing verification should be documents, it is decided to incorporate the CPV policy at site. Bakshi (QA
Process Verification. carried out. Frequency and volume can be SOP & Protocol for the CPV is under preparation & expected to Head)
selected by the manufacturer based on be completed & implemented before 30-12-19.
knowledge of the process, past results, etc.
23 Annex 15 Verification of transportation of Major Taking into account that there were still no As per the guidance from inspector & reference guidance 15-01-20 Mr. Sandeep
6.1 - 6.4 finished products has not been deliveries to Ukraine, it will be enough to documents, it is decided to incorporate the policy for Bakshi (QA
carried out. There is no procedure provide a prepared written procedure by Verification of Transportation of Finished Products at site. SOP Head)
for conducting such verification. which transportation verification will be & Protocol for the same is under preparation & expected to be
carried out. It is possible to demonstrate the completed & implemented before 15-01-20. Based on the
results of deliveries to other markets; this will recommendations, it is decided to perform the verification
be perceived positively as a demonstration activity for current supplies after approval from Corporate
of the company's abilities. Quality Experts.
24 5.27, 5.29 A system for assessing and Minor Raw material suppliers should be approved. Based on the guidance received from inspector & reference 28-02-20 Mr. Yogesh
approving raw material suppliers documents, it is decided that the Vendor Qualification Policy / Gangawane
has not been developed. SOP will be revised for detailed & clear procedural instructions (CQA Head)
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
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, it is decided that the SOP for Incoming Materials Gangawane
conformity of the supply chain is not materials are received at the warehouse, it is Controls / Receipt of RM will be revised for detailed & clear (CQA Head)
checked. necessary to check compliance and give an procedural instructions for the qualification & Approval of
assessment. Supply chain. Also the checklist for receipt of RM shall also be Mr. Sachin
revised to incorporate the provision of assessment of incoming Tyagi (WH

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materials for standard compliance. Entire activity will be Head)
implemented before 15-01-20.
26 Annex 16 For issued authorizations for sale of Minor For issued authorizations the register should As guided by the inspector, the SOP for “Issued Authorizations 20-12-19 Mr. Sachin
1.10.1 finished product batches the be maintained, for example, in the form of a for Sale of Finished Product Batches” will be implemented with Tyagi (WH
corresponding registers are not log. the provision of Log form to maintain the Issued Authorizations Head)
maintained (for example, in the form for Sale of Finished Product Batches. The SOP & record log will
of a log). be implemented before 20-12-19
27 5.10 In the production area, plastic bags Minor Since these plastic bags have direct contact Based on the recommendations & requirements, it is decided to 20-12-19 Mr. Manoj
are used for storing intermediate with the product and parts of the equipment, incorporate the practice & procedure of testing of plastic bags Sharma (QC
products and packaging parts of which in turn have contact with the product, which comes in direct contact with the product / materials. SOP Head)
equipment for their storage. these bags should be subjected to incoming for the same will be implemented. Specification & STP for
However, no incoming quality quality control, especially in terms of Plastic Bag will be revised to incorporate the assessment /
control of these bags is carried out. “Microbiological purity”. testing of Plastic Bags. However in current situation the
physical inspection, dimension verification & receipt of bags
only along with Food Grade Declaration Certificate from the
vendor is in practice & mandate.
The SOP & revised Specification and STP will be made
effective before 20-12-19.
6. Quality control
28 6.36 The assessment of the further Minor The assessment of trends can be an As guided & recommended by the expert, the SOP for Stability 20-12-19 Mr. Manoj
stability studies program is effective tool when summarizing Studies has been taken under revision to incorporate the Sharma (QC
supposed to be carried out at the intermediate results. procedural instructions & provision of assessment along with Head)
end of the program and not once the trending of each station / interval data in the report form. Mr. Sandeep
results are available at each stage Revised SOP & forms will be made effective before 20-12-19 Bakshi (QA
of the program. Head)
29 5.10 No incoming control is carried out on Major - As detailed in Point No. 27, it is decided to incorporate the 20-12-19 Mr. Manoj
the indicator “Microbiological purity” practice & procedure of testing of plastic bags which comes in Sharma (QC
of plastic bags, which are used to direct contact with contact parts. SOP for the same will be Head)
pack clean parts of equipment that implemented. Specification & STP for Plastic Bag will be
come into direct contact with revised to incorporate the physical, chemical & Microbiological
products. assessment / testing of Plastic Bags which are used to store
equipments change parts (contact parts), products & materials.
However in current situation the physical inspection, dimension
verification & receipt of bags only along with Food Grade
Declaration Certificate from the vendor is in practice &
mandate.
The SOP & revised Specification and STP will be made
30 Annex 11: The practice of verification the audit Major The verification procedure should be clearly Based on the recommendations & guidance from inspector, the 30-12-19 Mr. Manoj
9 trail of analytical studies involves the defined and described in the SOP. The fact SOP for “Audit Trail Management” will be revised for Sharma (QC
verification by the operator who of such an assessment and the result of the incorporation of audit trial verification procedure along with the Head)
conducted the analysis. assessment should be recorded. Audit Trail Checklist with detailed must checkpoints to be
The verification must be performed either by checked & reviewed by the reviewer for effective review of audit
a second laboratory technician or by the trail. The revised SOP & Checklist will be made effective &
head of the laboratory team. implemented before 30-12-19.
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

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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.
31 6.8 The analysis results for Ibuprofen Critical This situation can be evaluated as Based on the observations & guidance from the experts, it is 30-12-19 Mr. Manoj
contain test data from the contract falsification of data. decided that the SOP governing the Contract Analysis Services Sharma (QC
laboratory (Auriga). At the same Utilization will be revised to incorporate the defined procedure Head)
time, there is no certificate of for receipt of analysis reports from Contract Analysis Laboratory
analysis from the contract in defined format with identification & coding on the reports
laboratory. which authenticate the originality & legality of the report
received through Electronic Media (Mails). Also the instructions
to confirm, review & verify the 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
32 5.10 Instruments used for sampling raw Critical Instruments that have direct contact with the The observation has been taken under consideration 28-02-20 Mr. Sandeep
materials are washed and dried in product should be prepared in clean rooms immediately after the inspection & as per Action Plan designed Bakshi (QA
an unclassified laboratory room. or sterilized after preparation. for compliance, a new washing area will be constructed outside Head)
the dispensing area in warehouse premises with adequate
environmental & access controls. Area location & design with Mr. Robin
execution plan has been prepared & sent for final approval from Lukose
Corporate Quality Expert & Hired GMP Experts. The entire (Engg. Head)
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 The matter is under consideration & assessment with Technical NIR Mr. Sandeep
excipients are not identified. both active substances and excipients. Experts & Corporate Quality Experts for feasibility & way out for Bakshi (QA
implementation for the Excipients. The required arrangements Head)
for implementation are being assessed like provision of Mr. Robin
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.
34 5.33 The analysis results for the active Critical On detailed investigation, it is revealed that the in-house IR 20-12-19 Mr. Manoj
substance Paracetamol authorized Instrument was under maintenance during the inspection period Sharma (QC
for use do not contain the results of & the samples were sent to Contract Test Laboratory for Head)
the identification test of 80 bags that Identification testing as composite sample from all containers.
were received in one delivery. The CTL performed the identification on composite sample &
sent the report. On further investigation, it is found that the
Material was received from regular approved vendor & all the

174101

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.
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
Outsourced Analysis Activities, 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 addition to the above actions, Review by Second Line Sr.
Analyst Reviewer, Lab Head & Independent QA (AQA) Person
have been deputed for online review of QC activities w.r.t.
established procedures. All the proposed actions will be
completed before 20-12-19.
In addition to this the samples sent for Identification BY IR at
CTL during the In-house IR maintenance period are also
assessed for the similar discrepancy, but there is no other API
sent as composite sample of all containers for Identification by
IR.
35 6.21 The laboratory does not have a Minor An appropriate certificate should be Based on the guidance & requirements, the SOP for Handling 15-12-19 Mr. Manoj
certificate for a working reference available for all reference standards, of RWS is taken under revision to incorporate the receipt of Sharma (QC
standard of Ciprofloxacin. especially for those that are working qualification COA along with RWS at site. Qualification Head)
standards and are not Pharmacopeial. Certificates for the all available lots of RWS have been availed
at site QC Lab. Revised SOP will be made effective before 15-
12-19.
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.
36 6.24 Two autoclaves are installed in one Major Separation of use of this equipment in time As guided by the experts, the SOP has been taken under 30-03-20 Mr. Manoj
room of the microbiological is possible, but at the same time this revision to incorporate the procedural instructions to regulate Sharma (QC
laboratory: for sterilization and for requirement should be clearly regulated in the use of individual autoclave at a time without overlapping the Head)
decontamination of “contaminated” the SOP, and the fact of compliance with this activity of each other. Also the log record for the same will be
materials. The simultaneous use of requirement should be recorded and maintained to avoid the simultaneous use of both autoclaves at
these autoclaves can lead to evaluated. one time.
microbiological contamination of Moreover the microbiology laboratory is also under expansion &
sterilized materials. new area will have dedicated areas for each autoclave,which is
There is no procedure or any expected to be completed 30-03-20. Microbiological lab will be
visualization at the workplace about completely restructured to ensure compliance of regulatory as
the types of charges of the well as GLP/GMP requirements & to overcome the existing
autoclave used for sterilization. space constrains in current microbiology lab.

174101

Copy of proposed Layout of Microbiology Lab is attached as
Annexure-36(6.24).
37 6.7 There is no formalized sampling Minor For monitoring, we recommend to consider The SOP is under revision & updation to incorporate the 30-12-19 Mr. Manoj
plan for microbiological monitoring other sampling methods: active air sampling required Schedule / sampling plan for microbiological Sharma (QC
of production facilities. (aspiration method), sampling from surfaces monitoring of each production area. Sampling techniques like 15-01-20 Head)
For monitoring, only the and personnel. active air sampling (aspiration method), sampling from surfaces
sedimentation method on Petri and personnel recommended by the expert will also be
dishes is used. incorporated and implemented before15-01-20. Procurement
process for active air sampler has also been initiated &
expected to be received before 30-12-19.
38 5.10 There is no incoming control of Major Since these gloves are non-sterile, there is It is decided to incorporate the practice & procedure of testing 20-12-19 Mr. Manoj
gloves that the personnel use in no information on how they can be of hand gloves used in the process areas which comes in direct Sharma (QC
production rooms and which have contaminated, periodic monitoring is contact with the materials / products & equipments contact Head)
direct contact with products. necessary. It is advisable to audit the gloves parts. SOP for the same will be implemented. Specification &
manufacturer. 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 20-12-19.
The SOP, Specification and STP for Gloves will be made
39 6.15 The effectiveness of the "Hand Minor - As guided, the protocol for the qualification of hand sanitizer for 30-01-20 Mr. Manoj
Annex 15: Sanitizer" used by the personnel 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 As per directions & guidance of experts the protocol for RM & 15-01-20 Mr. Manoj
the quality control of raw materials laboratory where these methods are used. FP testing methods verification has been implemented & the Sharma (QC
and finished products is not carried verification activity is under process. Further the protocol for Head)
out. Microbiological Analysis Method Verification is under
For microbiological methods of preparation & finalization. Once the protocol will get approved &
quality control, validation effective, the verification activity will be initiated immediately.
(verification of the suitability of the The implementation of the protocol is expected to be completed
method) has not been performed. 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 is 30-01-20 Mr. Sandeep
7,7 contract laundry, the fact was not and prepare sufficient evidence of the decided to revise the Laundry Qualification Protocol to Bakshi (QA
established that there was no risk of absence of such a risk. incorporate the risk assessment for the chances of cross Head)
cross-contamination of clothes with contamination pf cloths at outsourced laundry. After revision of
medicinal products that the protocol, the outsourced laundry service providing facility
contaminated clothes brought for will be re-audited to assess the possible risks of contamination
washing from other enterprises. The & 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

174101

wash the clothes of the enterprise clothes of our firm together with clothes from other firms in any
together with clothes from other case. The entire activity will be completed before 30-01-20
enterprises that produce, for
example, penicillin or cephalosporin
antibiotics.
42 7.4 To manage outsourcing activities Minor There should be a clear written procedure As guided by the expert, the SOP for Outsourced Activities 30-12-19 Mr. Sandeep
there is no procedure that describes for this type of activity. Management is under preparation & expected to be completed Bakshi (QA
the Action Plan. & 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 30-12-19 Mr. Sandeep
recall procedures is not assessed. both for training and for real recall under revision to incorporate the procedural instructions to Bakshi (QA
procedures, the approach to the assessment assess the effectiveness of Recall procedure by carrying out Head)
should be included in the written procedure. periodic mock / training recall activity by considering possible
It is recommended to conduct a training hurdles in the recall process like weekend / holidays etc. The
recall also on a weekend / holiday. revised SOP will be made effective before 30-12-19 &
assessment of effectiveness of procedure will be carried out
before 30-01-20.

174101
ІІІ. Additional comments / recommendations

Sr. No. Comments / Recommendations Action Plan : Responsibility TCD
1. Conducting a company presentation at the As guided by the Inspection Expert, the Mr. Sandeep 15-01-20
first meeting with the inspectors, firm presentation is taken by QA (Mr. Bakshi
presentation content. The first impression Sandeep Bakshi) for suggested
depends on the presentation of the upgradation & recommendations. The
company, which is held at the first meeting existing presentation was provided by
with the inspectors, and it can be very Corporate Quality Assurance & includes
important. The presentation should include more details of Parent company i.e. M/s
information on the pharmaceutical quality Aarti Industries Ltd. & like more detailed
system of the enterprise and its main w.r.t. marketing promotions. The proposed
elements, policies and goals in the field of updations in the presentation will be
quality. It will also be useful to separately implemented before 15-01-20.
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 As guided by the Inspection Expert, the Mr. Ashok 30-12-19
unified training system should be provided recommended updations will be Chawla
before admission to “clean” production implemented through defined QMS (HR Head).
facilities. It is good practice to ask visitors procedures applicable. Specific policy will
about their health status during admission. be defined in the SOP under HR
When visiting production facilities, (hospitality & coordination controls)
someone of the company personnel department with detailed unified training
should always go first and show/explain system for visitor’s (including own firm
actions for guests. employees from Corporate Team who
visits the site). proposed SOP &
implementation will be completed before
30-12-19
3. To develop a sampling plan for raw As guided by the Inspection Expert, the Mr. Manoj 30-01-20
materials and packaging materials, it is respective SOP will be revised for Sharma (QC
recommended to use the ISO 2859 recommended updations in the SOP. For head)
standard. The same approach applies Sampling SOP, QC Dept. will revise their
when developing a sampling plan for respective SOP & for Process Validation, Mr. Sandeep
technological process validation. QA Dept. will revise the SOP for Process Bakshi (QA
Validation. The revision & implementation Head)
of revised SOP will be done before 30-01-
20
4. When approving manufacturers and As guided by the Inspection Expert, the Mr. Yogesh 28-02-20
suppliers (distributors) of active recommended updations are being (CQA)
pharmaceutical ingredients (API), their reviewed & implementation Action Plan
audits is a prerequisite. Only after approval will be designed & completed before 28-
can they appear in the List of Approved 02-20.
Suppliers.
5. Each supply of raw materials and As guided by the Inspection Expert, the Mr. Sandeep 30-01-20
packaging materials (admission to the recommended updations will be Bakshi
warehouse) should be evaluated in terms incorporated in the system procedures & (QA Head)
of supply chain compliance. To do this, the SOP will be prepared & implemented for 28-02-20
enterprise must have an approved supply the same. SOP preparation will be done Mr. Yogesh
chain for each item. before 30-01-20 (By site QA) & (CQA)
implementation Action Plan will be
designed & completed by CQA before 28- Mr. Sachin
02-20 (Responsibility Assigned to Mr. Tyagi
Report // Pinnacle Life science Pvt Ltd. // India // 10.2019
14/19
174101

Sandeep Bakshi (QA Head), . (WH Head)
6. In the personnel dressing rooms the As guided by the Inspection Expert, the Mr. Ashok 28-02-20
visualization of such procedures is used. It recommended updations will be Chawla (HR
is also recommended to place visualization incorporated in the system & SOP will be Head) 28-02-20
of dressing procedures not only for the prepared & implemented for the same.
personnel of the enterprise, but also for SOP preparation w.r.t visitors will be done Mr. Harish 28-02-20
visitors, since different clothes and before 30-01-20 (By HR Dept.) under Senger (PR
different dressing procedures are used. It Quality Head’s Guidance. Implementation Head).
is also recommended to supplement the of SOP & completion of display /
visualization of exit procedures from visualization as per SOP will be Mr. Sachin
production facilities, since the correct completed before 28-02-20 (Responsibility Tyagi (WH
implementation of these procedures is also Assigned to Mr. Ashok Chawla (HR Head) &
important. It should also be noted that in Head).
most locks for personnel dressing there Existing Entry Exit SOP for Production Mr. Manoj
are no sinks and devices for hand- Block for own employees (site personnel) Sharma (QC
washing. will be revised for recommended Head).
upgradation (By PR Incharge).
Implementation of revised SOP &
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).
7. When preparing technological process As guided by the Inspection Expert & Mr. Sandeep 30-01-
validation protocols, it is recommended to reference guidance document (EU GMP Bakshi 20
pay attention to the study and Annex 15), it is decided to revise the (QA Head) &
establishment of critical process existing SOP governing Process
parameters (CPP), critical quality attributes Validation Activity at site. The SOP will be Mr. Harish
(CQA) and acceptance criteria. It is good revised to incorporate all the sections Senger (PR
practice of development of such specified in the reference document, Head) &
parameters to conduct a risk analysis inspector’s guidance, identification of
before developing a process validation CPP, CQA through risk assessment & Mr. Manoj
protocol (EU GMP Annex 15: cl. 5.21). acceptance criteria for the same. Based Sharma (QC
It is expected that the Process Validation on the revised SOP, the Protocol for the Head).
Protocols will contain at least all the Process Validation of each formulation will
sections specified in clause 5.22 of Annex also be revised & further validation activity
15 of EU GMP. 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).
8. The positions that can fulfil the duties of As guided by the Inspection Expert, the Mr. Sandeep 28-02-
the Qualified Person (QP) of the enterprise JD of QP & his/her designee will be made Bakshi (QA 20.
in case of its absence (vacation, business inline with the EU GMP Guidance Head).
trip etc.) should be clearly defined. Their Document recommendations &
job description should state that they can requirements. A defined policy will be
be appointed to perform such duties. The implemented detailing details of duties
Qualified Person of the enterprise can governed by QP. Also the delegation of
conduct an additional assessment and QP’s duties to his designee in any case

15/19
174101

release of the batch, since only duties can will be clearly detailed in the policy &
be delegated, but not responsibility, i.e. in same will be followed strictly. Accordingly
any case, the QP should and will be the SOP governing the procedure of
responsible for the batch release. 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).
9. Attention should be paid to the risk of As guided by the Inspection Expert, a Mr. Sandeep 30-03-
cross-contamination in the production of detailed risk assessment will be carried Bakshi 20
the antibiotic Azithromycin. The joint out for the worst case scenario &
production of antibiotics and non- possibilities of Azithromycin cross
antibiotics will attract the attention of contamination and available control
inspectors. It is possible, to demonstrate measures & identification of requirements
intentions to minimize the risk of cross- of additional control measures based on
contamination, to prepare a risk identified risks. The activity will be
assessment document in which one should completed before 30-03-20.
assess all possible sources of (Responsibility Assigned to Mr. Sandeep
contamination and provide measures to Bakshi (QA Head).
minimize such risks.
10. Sampling of finished products should As guided by the Inspection Expert, the Mr. Sandeep 30-01-
ensure the representativeness of the existing system reviewed & revealed that Bakshi (QA 20
sample taken, often this is ensured by the SOP is available for sampling of Head).
sampling at the beginning, middle and end Inprocess & Finished Goods is available
of the packaging process. This approach but detailed procedure to collect the
should be clearly defined and described in samples as initial middle & end plan is not
the relevant SOPs, and the fact of described in the SOP. However the
sampling should be recorded (for example, procedure & sampling activity record in
in the batch production protocol). BNR/BPR is with provision of initial middle
& end of the process of any stage. Thus
now it is decided that the 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).
11. Workplaces should have recorded copies Based on the observation & Mr. Sandeep 30-03-
of written procedures – SOPs or extracts recommendations by inspection expert, it Bakshi (QA 20.
from them. These SOPs or extracts were is decided to implement the policy to Head),
not always at workplaces, for example, maintain copies of standard procedures in Mr. Harish
near the autoclave located in the the workplace near to the workstation of Senger (PR
microbiological laboratory and in which equipment / instruments along with the Head),
sterilization of nutrient media takes place, recorded logs for the same. In addition to Mr. Manoj
there is no written procedure or extract this the policy will also be incorporated Sharma (QC
from SOPs or visualization of autoclave with procedure to incorporate visualization Head),
loading. This practice may be the reason pictorial extracts of the procedure in the Mr. Sachin
for inconsistency during the official respective SOP & same will be displayed Tyagi (WH
inspection with the wording that there are at workplace near to work station / Head),
no instructions at the operator’s workplace, equipment / instruments to achieve Mr. Amit
etc. lifecycle consistency at workplace. Kumar (MN
Along with the preparation & updation of Head),
policies, training will be imparted to all Mr. Ashok
concerned personnel before Chawla (HR
implementation. Entire activity will be Head).
completed before 30-03-20.

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(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 Based on the observation & Mr. Sandeep 30-03-
to verify validation/qualification results with recommendations by inspection expert, it Bakshi (QA 20
written procedures used in the routine is decided to review each & every Head),
process. For instance, autoclave Qualification & Validation SOP, Protocols Mr. Harish
sterilization validation – the loading & Reports for its completeness & based Senger (PR
methods described in SOPs must be on the review outputs, required updations, Head),
validated; based on the results of a study revisions will be done to upgrade the Mr. Manoj
of the temperature distribution in the system compliant with current regulatory Sharma (QC
warehouses for raw materials and finished requirements & expectations. A review Head),
products storage, places for routine task force will be deputed for the Mr. Sachin
temperature monitoring are selected; proposed Action Plan. The task force will Tyagi (WH
sterilization modes in the tunnel sterilizer be comprised of SME from CFT Head),
(temperature, conveyor belt speed) should departments like QC, QA, MN, PR, IT, Mr. Amit
coincide or have reasonable differences; HR. The entire activity will be completed Kumar (MN
etc. before 30-03-20 (Responsibility Assigned Head),
to Mr. Sandeep Bakshi (QA Head), Mr. Mr. Ashok
Harish Senger (PR Head), Mr. Manoj Chawla (HR
Sharma (QC Head), Mr. Sachin Tyagi Head).
(WH Head), Mr. Amit Kumar (MN Head),
Mr. Ashok Chawla (HR Head).
13. Measures to eliminate identified deviations Based on the guidance document Mr. Sandeep 30-12-
during the self-inspection should be (Chapter 9 Self Inspection) & Bakshi (QA 19
developed by the responsible personnel of recommendations given by inspection Head),
the structural unit in which the self- expert, it is decided to revise the existing Mr. Harish
inspection was carried out. SOP for Self Inspection Activity to Senger (PR
incorporate the procedure & detailed Head),
format for recording the observations & Mr. Manoj
inspection report preparation. Compliance Sharma (QC
report format & verification of conformity & Head),
compliance CAPA implementation & Mr. Sachin
closure review report with certificate. Tyagi (WH
Entire activity will be completed & Head),
implemented before 30-12-19. Mr. Amit
(Responsibility Assigned to Mr. Sandeep Kumar (MN
Bakshi (QA Head), Mr. Harish Senger (PR Head),
Head), Mr. Manoj Sharma (QC Head), Mr. Mr. Ashok
Sachin Tyagi (WH Head), Mr. Amit Kumar Chawla (HR
(MN Head), Mr. Ashok Chawla (HR Head) Head)
i.e Entire SI team under Quality Heads
Guidance
14. The list of documents of the enterprise Based on the guidance document Mr. Sandeep 30-12-
quality system is recommended to be (Chapter 4 Documentation) & Bakshi (QA 19.
drawn up in the form of a schedule that recommendations given by inspection Head).
would reflect the review date and record expert, it is decided to revise the existing
the result (whether it was reviewed or not, SOP for Documents & Data Control to
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 Based on the guidance document Mr. Robin 30-01-
system for blocking the simultaneous (Chapter 3 - Premise and Equipment) & Lukose 20
opening of two doors of a lock or a warning recommendations given by inspection
system for simultaneous opening of a lock. expert, it is decided to install interlocking Mr. Anil

17/19
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For example, a lock in a raw material systems with Alarm in all personnel & Kumar
sampling area. material airlocks at entire facility. The Baliyan (GM
installation work will be completed before Operations)
30-01-20. (Responsibility Assigned to Mr.
Robin Lukose under guidance of Mr. Anil Mr. Sandeep
Kumar Baliyan (GM Operations) & Mr. Bakshi (QA
Sandeep Bakshi (QA Head). Head).
16. For production facilities, warehouse Based on the guidance document Mr. Robin 30-01-
premises and quality control rooms, strict (Chapter 3 - Premise and Equipment) & Lukose 20
access control should be in place to recommendations given by inspection
prevent passage of personnel who do not expert, it is decided to install biometric Mr. Anil
work in these rooms. access controls systems in all sections / Kumar
cubicles / areas at entire facility to restrict Baliyan (GM
the unauthorized entry in any of the area. Operations)
The installation work will be completed
before 30-01-20. (Responsibility Assigned Mr. Sandeep
to Mr. Robin Lukose under guidance of Bakshi (QA
Mr. Anil Kumar Baliyan (GM Operations) Head)
& Mr. Sandeep Bakshi (QA Head)
17. In some production facilities, Major Based on the observations, the repair & Mr. Robin 28-02-
damage to the floor, walls, and ceiling of maintenance work of entire flooring & Lukose 19
other structural elements is observed. For damages to entire facility controlled & under
example, Major damage to the floor was classified areas has been initiated in guidance of
observed in the granulation room, and the phased manner & expected to be Mr. Anil
floor was also severely damaged in the completed before 28-02-19. Further the Kumar
washing room. Inspector's expectations – SOP for Building / Facility Maintenance Baliyan (GM
all elements of clean rooms should be will be revised to incorporation of BMS Operations)
even and smooth to ensure proper Team for compliance of the SOP & & Mr.
cleaning. scheduled facility preventive maintenance Sandeep
program will be implemented strictly. BMS Bakshi (QA
team will be formed by GM Operations in Head).
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 Based on the observations & Mr. Harish 30-01-
the door closures. All elements that are in recommendations & guidance provided by Senger (PR 20
clean rooms should be carefully cleaned. the inspection expert, the respective area Head), Mr.
The relevant procedures should list the & equipment cleaning SOP are taken Manoj
items to be cleaned: watches, fire under revision to incorporate the area & Sharma (QC
extinguishers, video cameras, etc. equipment list of items to be cleaned like Head), Mr.
clocks, watches, hygrometers, Table Top, Sachin Tyagi
cross over bench, Garment Cabinets, VTS (WH Head),
Closures, Pallets, SS Trolley, SS Material Mr. Amit
Transfer cabinets, rejection bins, Kumar (MN
accessories, cutters, hammers, SS Bins & Head), Mr.
Bowls, fire extinguishers, video cameras Ashok
etc. New SOP will be prepared along with Chawla (HR
Checklists for the items which are Head), Mr.
available in classified & controlled areas Sandeep
but not covered or governed under any Bakshi (QA
SOP. Entire activity will be completed Head)
before 30-01-20.
19. Attention should be paid to one of the On review of activity & documents, it is Mr. Harish 30-01-
processes of packing tablets and capsules. observed that the SOP for Packing of Senger (PR 20
During the stop of the packaging machine, Products will be revised to include the Head), Mr.
part of the already packaged tablets or checklist with checkpoints to discard the Sandeep
capsules is exposed to high temperature part of the already packaged tablets or Bakshi (QA
from the sealing plate (temperature can be capsules is exposed to high temperature Head).
2000С and higher). It is normal practice to from the sealing plate in case of machine

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discard blisters that have been exposed to stop. Provision to record the same in BPR
excessive temperature. Such a system & verification by concerned IPQA
should work in a routine, and its personnel will be incorporated. The entire
performance should be confirmed during activity will be completed before 30-01-20
validation.
20. The personnel training procedures should Based on the guidance provided by the Mr. Harish 28-02-
have clear and detailed instructions on the inspection expert, it is decided to provide Senger (PR 20.
hand washing procedure and the hand hand washing facility in the primary Head), Mr.
disinfection procedure. These may be personnel airlocks/change rooms for hand Manoj
separate procedures; it is possible to refer washing & SOP for the same incorporate Sharma (QC
to them in the procedures for personnel the procedure of hand washing & Head), Mr.
training. It is recommended to place disinfection procedure along with pictorial Sachin Tyagi
visualization of washing and disinfection displays & training to all concerned as (WH Head),
procedures for hands in the personnel basic requirement of personnel hygiene. Mr. Amit
locks. The personnel training should also The Pictorials displays along with the Kumar (MN
include visualization of the dressing procedure to follow the same will be Head), Mr.
procedure (for entry and exit) for both incorporated in the SOP & training Ashok
employees and guests, the corresponding modules & reference form number will be Chawla (HR
images should be placed in the locks. All allocated to ensure synchronization of Head) under
photographs should contain links to the Displays with respective SOP. Entire technical
procedure, which provides this Action activity will be completed before 28-02- guidance of
Plan when changing clothes 20 Site Quality
Head)
.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.
Compliance Report & CAPA Plan Drafted By : Dr. Deepak K Thakur

Dated : 12-12-19
Ref : https://europa.eu/halth/documnts/eudra_en

19/19

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PINNACLE LIFE SCIENCE PVT. LTD.

REPORT ON THE ASSESSMENT OF THE PHARMACEUTICAL QUALITY

Enterprise: Pinnacle Life science Pvt. Ltd.

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

Report // Pinnacle Life science Pvt Ltd. // India // 10.2019 1/19

Assessed activities: Manufacture of finished medicinal products

Date: 09.10 - 11.10.2019

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

EudraLex The Rules Governing Medicinal Products in the European Union

Auditor: Aleksey Sukhomlynov , expert / consultant GMP / GDP

Report // Pinnacle Life science Pvt Ltd. // India // 10.2019 2/19

ІІ. DEVIATIONS IDENTIFIED

Deviations, observations, recommendations for elimination and/or comments:

Report // Pinnacle Life science Pvt Ltd. // India // 10.2019 3/19

GMP EC Qualification Compliance & CAPA Plan

Report // Pinnacle Life science Pvt Ltd. // India // 10.2019 4/19

GMP EC Qualification Compliance & CAPA Plan

Report // Pinnacle Life science Pvt Ltd. // India // 10.2019 5/19

GMP EC Qualification Compliance & CAPA Plan

Report // Pinnacle Life science Pvt Ltd. // India // 10.2019 6/19

GMP EC Qualification Compliance & CAPA Plan

Report // Pinnacle Life science Pvt Ltd. // India // 10.2019 7/19

GMP EC Qualification Compliance & CAPA Plan

Report // Pinnacle Life science Pvt Ltd. // India // 10.2019 8/19

GMP EC Qualification Compliance & CAPA Plan

Report // Pinnacle Life science Pvt Ltd. // India // 10.2019 9/19

GMP EC Qualification Compliance & CAPA Plan

Report // Pinnacle Life science Pvt Ltd. // India // 10.2019 10/19

GMP EC Qualification Compliance & CAPA Plan

Report // Pinnacle Life science Pvt Ltd. // India // 10.2019 11/19

GMP EC Qualification Compliance & CAPA Plan

Report // Pinnacle Life science Pvt Ltd. // India // 10.2019 12/19

GMP EC Qualification Compliance & CAPA Plan

8. Complaints, quality defects and recalls

Report // Pinnacle Life science Pvt Ltd. // India // 10.2019 13/19

ІІІ. Additional comments / recommendations

Sr. No. Comments / Recommendations Action Plan : Responsibility TCD

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

Sr. No. Comments / Recommendations Action Plan : Responsibility TCD

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

Sr. No. Comments / Recommendations Action Plan : Responsibility TCD

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

Sr. No. Comments / Recommendations Action Plan : Responsibility TCD

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

Sr. No. Comments / Recommendations Action Plan : Responsibility TCD

Compliance Report & CAPA Plan Drafted By : Dr. Deepak K Thakur

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

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