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Project Work DQAC 31 OCT 2021
Project Work DQAC 31 OCT 2021
FOR
VALIDATION OF ASEPTIC OPERATION OF STERILE OPHTHALMIC SUSPENSIONS ON
THREE PIECE FILLING LINE BY PROCESS SIMULATION/ MEDIA FILL
MUKESH SHARMA
REGISTRATION No. DAQC/3/21-09
SENTISS PHARMA PRIVATE LIMITED
VILLAGE: KHERA NIHLA, TEHSIL: NALAGARH, DISTRICT: SOLAN,
HIMACHAL PRADESH, INDIA.
This document is proprietary & confidential. It may not be disclosed or reproduced, in whole or in part, without written consent of COMPANY NAME.
COMPANY LOGO INTERNAL QUALITY AUDIT REPORT
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COMPANY LOGO INTERNAL QUALITY AUDIT REPORT
Time Activity
09:00 to 09:15 Opening meeting with representatives of Validation,
Production, Microbiology and Quality Assurance.
09:15 to 10:00 Inspection of moist heat steriliser/ autoclave (ID: PR1 and
MI1).
10:10 to 11:30 Review of sterilization record of machine parts and media.
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COMPANY LOGO INTERNAL QUALITY AUDIT REPORT
Time Activity
11:30 to 13:30 Review of environmental monitoring by active air sampling
and passive air sampling.
13:30 to 14:00 Lunch Break
14:00 to 15:00 Review of environmental monitoring programme by active air
sampling and passive air sampling.
15:00 to 17:00 Review of personnel monitoring programme.
17:00 to 17:15 Discussion between auditors on observations and findings.
17:15 to 17:30 Closing meeting with representatives of Validation,
Production, Microbiology and Quality Assurance.
Time Activity
09:00 to 09:15 Opening meeting with representatives of Validation,
Production, Microbiology and Quality Assurance.
09:15 to 10:30 Review of sterilization record of sterile gowning.
10:30 to 11:30 Review of gowning qualification and personnel qualification
of participants in process simulation.
11:30 to 13:30 Review of process simulation/ media fill batch record (Batch
No. 2021MF1 and 2021MF2) against sterile ophthalmic
suspensions processes of Briti and Texa (Batch No. B101 and
T102).
13:30 to 14:00 Lunch Break
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COMPANY LOGO INTERNAL QUALITY AUDIT REPORT
Time Activity
14:00 to 16:00 Review of process simulation/ media fill batch record (Batch
No. 2021MF1 and 2021MF2) against sterile ophthalmic
suspensions processes of Briti and Texa (Batch No. B101 and
T102).
16:00 to 17:00 Effectiveness Check of previous internal audit.
17:00 to 17:15 Discussion between auditors on observations and findings.
17:15 to 17:30 Closing meeting with representatives of Validation,
Production, Microbiology and Quality Assurance.
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COMPANY LOGO INTERNAL QUALITY AUDIT REPORT
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COMPANY LOGO INTERNAL QUALITY AUDIT REPORT
3.5.2 Steriliser (ID: MI1): The sterilisation records of media were reviewed and
following was observed;
Load pattern for sterilising the machine parts was defined in the SOP No.
MI001-00.
Overkill approach was used for sterilisation.
Bowie Dick test was pass.
Steam quality test report was reviewed. The amount of non-condensable
gas was less than 3.5 ml of gas per 100 ml of condensate as required by
EN 285.
The printout of sterilisation cycles was reviewed and all the 10
thermocouples had logged temperature above 121.1°C.
The cycle time of minimum 30 minutes was met.
F0 value achieved was 37 minutes.
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COMPANY LOGO INTERNAL QUALITY AUDIT REPORT
3.5.3 Process Simulation/ Media Fill Batch Record of Batch No. 2021MF1 was
reviewed against products Briti and Texa (Batch No. B101 and T102
respectively) and following was observed;
The batch record was developed from the SOP No. MF001-00.
The temperature was maintained between 25±2°C.
SCDM was the media of choice for process simulation.
Only 2 operators were there in the manufacturing room.
Audit Observation: Filtration was performed using the 10μ filter.
Whereas, Briti (Batch No. B101) used 10μ filter, Texa (Batch No. T102)
used 20μ filter for API and excipient solution filtration.
The filling machine setup was accomplished with 2 primary operators and
1 secondary operator.
6 personnel were there in the filling room. The filling room is qualified
occupancy of 5.
10,000 vials of 15 ml were filled.
Fill volume was adjusted to not less than 13.5 ml.
Routine speed was 30 to 80 vials per minute. The worst case being 30 vials
per minute.
The duration of process simulation was 5 shifts. During regular production
the suspension process lasts 4 shifts.
Each of the 5 personnel were in filling room for up to 6 hours as non-
routine corrective intervention during process simulation.
The air handling unit was switched off in filling room and adjacent rooms
for 4 minutes to simulate power failure.
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COMPANY LOGO INTERNAL QUALITY AUDIT REPORT
All the filled vials were visually inspected for any defects.
The vials were incubated in upright position for 7 days at 20-25°C and next
7 days in inverted position for 30-35°C.
No growth was observed at the end of incubation period.
3.5.4 Process Simulation/ Media Fill Batch Record of Batch No. 2021MF2 was
reviewed against products Briti and Texa (Batch No. B101 and T102
respectively) and following was observed;
The batch record was developed from the SOP No. MF001-00.
The temperature was maintained between 25±2°C.
SCDM was the media of choice for process simulation.
Only 2 operators were there in the manufacturing room.
Audit Observation: Filtration was performed using the 10μ filter.
Whereas, Briti (Batch No. B101) used 10μ filter, Texa (Batch No. T102)
used 20μ filter for API and excipient solution filtration.
The filling machine setup was accomplished with 2 primary operators and
1 secondary operator.
5 personnel were there in the filling room. The filling room had qualified
occupancy of 5.
10,000 vials of 10 ml were filled.
Fill volume was adjusted to not less than 8 ml.
Routine speed was 30 to 80 vials per minute. The worst case being 30 vials
per minute.
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COMPANY LOGO INTERNAL QUALITY AUDIT REPORT
3.5.5 Training records of operators was reviewed and following was observed;
The participants were trained on aseptic techniques, aseptic behaviour,
basics of microbiology and interventions they were assigned to perform
during process simulation.
The primary operator was trained in machine part assembly, addition of
primary packaging material, interventions inside the ORABS, aseptic
connection in filtration, sterile product filter installation, purging of
solution and environmental monitoring viz. active, passive and non-viable
particle monitoring inside the ORABS.
The secondary operator was trained in machine/ area/ equipment
cleaning and sanitisation, material transfer in filling room, machine parts
unloading from moist heat steriliser/ autoclave, documentation in ISO 6/
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COMPANY LOGO INTERNAL QUALITY AUDIT REPORT
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COMPANY LOGO INTERNAL QUALITY AUDIT REPORT
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COMPANY LOGO INTERNAL QUALITY AUDIT REPORT
3.12 Glossary:
Audit: Systematic, independent and documented process for obtaining
objective evidence and evaluating it objectively to determine the extent to
which the audit criteria are fulfilled.
Audit Conclusion: Outcome of an audit, after consideration of the audit
objectives and all audit findings.
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COMPANY LOGO INTERNAL QUALITY AUDIT REPORT
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Audit Report No.: 2021/QA/007
COMPANY LOGO INTERNAL QUALITY AUDIT REPORT
Audited Department: Validation
Audit Date: 21 and 22 SEP 2021 Auditor: Akhilesh Srivastava, Mukesh Auditee: Yogesh Sharma, Jaswinder Rana,
Sharma Manmit Khale
Audit Audit Finding Classification Reference of Audit Criteria CAPA Plan with Target
Finding Completion Date
No.
1. The validation of aseptic Critical. 1. Guidance for Industry: Correction: Not applicable.
operation of sterile ophthalmic Sterile Drug Products
suspensions on three piece Produced by Aseptic Corrective Action:
filling line by process Processing – Current Good a) The next semi-annual
simulation/ media fill does not Manufacturing Practice validation of aseptic
closely simulate aseptic a) IX. Validation of aseptic operation of sterile
manufacturing operations processing and sterilization ophthalmic suspensions on
incorporating the worst-case A. Process Simulation three piece filling line by
activity and conditions at least at process simulation/ media fill
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Audit Report No.: 2021/QA/007
COMPANY LOGO INTERNAL QUALITY AUDIT REPORT
Audited Department: Validation
Audit Date: 21 and 22 SEP 2021 Auditor: Akhilesh Srivastava, Mukesh Auditee: Yogesh Sharma, Jaswinder Rana,
Sharma Manmit Khale
Audit Audit Finding Classification Reference of Audit Criteria CAPA Plan with Target
Finding Completion Date
No.
one incidence wherein the An aseptic processing planned in FEB 2022 shall use
ophthalmic suspension operation should be 20μ filter for mixing of API and
manufacturing process of validated using a Excipients considering it as a
product Briti (Batch No. B101) microbiological growth worst-case. (TCD: FEB 2022)
sterile product uses the 10μ medium in place of the
filter for filtering the mixture of product. This process b) Production, Validation and
API and excipients, and product simulation, also known as a Quality Assurance shall
Texa (Batch No. T102) media fill, normally includes prepare an Impact
ophthalmic suspension process exposing the microbiological Assessment to assess adverse
uses the 20μ filter for API and growth medium to product effect of this non-conformity
excipient solution filtration. contact surfaces of on safety, identity, strength,
Whereas the process simulation equipment, container quality, purity and efficacy of
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Audit Report No.: 2021/QA/007
COMPANY LOGO INTERNAL QUALITY AUDIT REPORT
Audited Department: Validation
Audit Date: 21 and 22 SEP 2021 Auditor: Akhilesh Srivastava, Mukesh Auditee: Yogesh Sharma, Jaswinder Rana,
Sharma Manmit Khale
Audit Audit Finding Classification Reference of Audit Criteria CAPA Plan with Target
Finding Completion Date
No.
for the suspension process is closure systems, critical batches of finished
performed using the 10μ filter environments, and process pharmaceutical products
with no documented rationale. manipulations to closely manufactured on three piece
In the above filtration schemes simulate the same exposure line since the start of
the process using the 20μ filter that the product itself will manufacturing of Texa
in Briti (Batch No. B101) for undergo. ophthalmic suspension
mixing of API and Excipients is process. (TCD: NOV 2021)
worst case considering the bio- b) 1. Study Design
burden point of view. Media fill studies should Preventive Action:
closely simulate aseptic Process simulation/ media fill of
manufacturing operations sterile ophthalmic suspension
incorporating, as process and sterile ophthalmic
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Audit Report No.: 2021/QA/007
COMPANY LOGO INTERNAL QUALITY AUDIT REPORT
Audited Department: Validation
Audit Date: 21 and 22 SEP 2021 Auditor: Akhilesh Srivastava, Mukesh Auditee: Yogesh Sharma, Jaswinder Rana,
Sharma Manmit Khale
Audit Audit Finding Classification Reference of Audit Criteria CAPA Plan with Target
Finding Completion Date
No.
appropriate, worst-case solution process on all
activities and conditions that manufacturing lines for last 2
provide a challenge to years shall be revisited to
aseptic operations. determine;
a) There is no gap in the
2. 21 CFR Part 211: Current validated manufacturing
Good Manufacturing process and process
Practice for Finished simulation/ media fill. (TCD:
Pharmaceuticals DEC 2021)
Sec. 211.113 Control of
microbiological b) Process simulation/ media fill
contamination. simulates by incorporating
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Audit Report No.: 2021/QA/007
COMPANY LOGO INTERNAL QUALITY AUDIT REPORT
Audited Department: Validation
Audit Date: 21 and 22 SEP 2021 Auditor: Akhilesh Srivastava, Mukesh Auditee: Yogesh Sharma, Jaswinder Rana,
Sharma Manmit Khale
Audit Audit Finding Classification Reference of Audit Criteria CAPA Plan with Target
Finding Completion Date
No.
(b) Appropriate written the worst-case activity and
procedures, designed to conditions. (TCD: DEC 2021)
prevent microbiological
contamination of drug
products purporting to be
sterile, shall be established
and followed. Such
procedures shall include
validation of all aseptic and
sterilization processes.
4.1 Notification to Management: Quality Assurance department shall apprise the top management of this critical audit finding
as defined in the SOP on Notification to Management.
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Audit Report No.: 2021/QA/007
COMPANY LOGO INTERNAL QUALITY AUDIT REPORT
Audited Department: Validation
Audit Date: 21 and 22 SEP 2021 Auditor: Akhilesh Srivastava, Mukesh Auditee: Yogesh Sharma, Jaswinder Rana,
Sharma Manmit Khale
Biennially the Quality Assurance department shall trend non-compliances/ non-conformities in process simulation/
media fill and present it to the top management during Quality Metrics presentation.
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INTERNAL QUALITY AUDIT CHECKLIST FOR
COMPANY LOGO
PROCESS SIMULATION
Audit Report No.: 2021/QA/007 Audit Date: 21 and 22 SEP 2021
Audited Department: Validation, Production, Microbiology and Quality Assurance
The checklist can be used as a guidance for auditing process simulation/ media fill on
the basis of 21 CFR Part 211.
Checkpoint Complies (Yes or No)
Buildings and Facilities Not applicable (NA)
1. 21 CFR 211.42(b) The flow of components, drug Yes.
product containers, closures, labeling, in-process
materials, and drug products through the
building or buildings shall be designed to prevent
contamination.
2. 21 CFR 211.42(c) Operations shall be performed Yes.
within specifically defined areas of adequate size.
There shall be separate or defined areas or such
other control systems for the firm’s operations as
are necessary to prevent contamination or
mixups during the course of the following
procedures:
3. (10) Aseptic processing, which includes as
appropriate:
4. (i) Floors, walls, and ceilings of smooth, hard
surfaces that are easily cleanable;
5. (ii) Temperature and humidity controls;
6. (iii) An air supply filtered through high-efficiency
particulate air filters under positive pressure,
regardless of whether flow is laminar or
nonlaminar;
7. (iv) A system for monitoring environmental
conditions;
8. (v) A system for cleaning and disinfecting the
room and equipment to produce aseptic
conditions;
9. (vi) A system for maintaining any equipment used
to control the aseptic conditions.
10. 21 CFR 211.46(b) Equipment for adequate Yes.
control over air pressure, micro-organisms, dust,
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INTERNAL QUALITY AUDIT CHECKLIST FOR
COMPANY LOGO
PROCESS SIMULATION
Audit Report No.: 2021/QA/007 Audit Date: 21 and 22 SEP 2021
Audited Department: Validation, Production, Microbiology and Quality Assurance
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INTERNAL QUALITY AUDIT CHECKLIST FOR
COMPANY LOGO
PROCESS SIMULATION
Audit Report No.: 2021/QA/007 Audit Date: 21 and 22 SEP 2021
Audited Department: Validation, Production, Microbiology and Quality Assurance
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INTERNAL QUALITY AUDIT CHECKLIST FOR
COMPANY LOGO
PROCESS SIMULATION
Audit Report No.: 2021/QA/007 Audit Date: 21 and 22 SEP 2021
Audited Department: Validation, Production, Microbiology and Quality Assurance
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INTERNAL QUALITY AUDIT CHECKLIST FOR
COMPANY LOGO
PROCESS SIMULATION
Audit Report No.: 2021/QA/007 Audit Date: 21 and 22 SEP 2021
Audited Department: Validation, Production, Microbiology and Quality Assurance
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INTERNAL QUALITY AUDIT CHECKLIST FOR
COMPANY LOGO
PROCESS SIMULATION
Audit Report No.: 2021/QA/007 Audit Date: 21 and 22 SEP 2021
Audited Department: Validation, Production, Microbiology and Quality Assurance
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INTERNAL QUALITY AUDIT CHECKLIST FOR
COMPANY LOGO
PROCESS SIMULATION
Audit Report No.: 2021/QA/007 Audit Date: 21 and 22 SEP 2021
Audited Department: Validation, Production, Microbiology and Quality Assurance
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INTERNAL QUALITY AUDIT CHECKLIST FOR
COMPANY LOGO
PROCESS SIMULATION
Audit Report No.: 2021/QA/007 Audit Date: 21 and 22 SEP 2021
Audited Department: Validation, Production, Microbiology and Quality Assurance
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INTERNAL QUALITY AUDIT CHECKLIST FOR
COMPANY LOGO
PROCESS SIMULATION
Audit Report No.: 2021/QA/007 Audit Date: 21 and 22 SEP 2021
Audited Department: Validation, Production, Microbiology and Quality Assurance
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INTERNAL QUALITY AUDIT CHECKLIST FOR
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PROCESS SIMULATION
Audit Report No.: 2021/QA/007 Audit Date: 21 and 22 SEP 2021
Audited Department: Validation, Production, Microbiology and Quality Assurance
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INTERNAL QUALITY AUDIT CHECKLIST FOR
COMPANY LOGO
PROCESS SIMULATION
Audit Report No.: 2021/QA/007 Audit Date: 21 and 22 SEP 2021
Audited Department: Validation, Production, Microbiology and Quality Assurance
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INTERNAL QUALITY AUDIT CHECKLIST FOR
COMPANY LOGO
PROCESS SIMULATION
Audit Report No.: 2021/QA/007 Audit Date: 21 and 22 SEP 2021
Audited Department: Validation, Production, Microbiology and Quality Assurance
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INTERNAL QUALITY AUDIT CHECKLIST FOR
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PROCESS SIMULATION
Audit Report No.: 2021/QA/007 Audit Date: 21 and 22 SEP 2021
Audited Department: Validation, Production, Microbiology and Quality Assurance
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INTERNAL QUALITY AUDIT CHECKLIST FOR
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PROCESS SIMULATION
Audit Report No.: 2021/QA/007 Audit Date: 21 and 22 SEP 2021
Audited Department: Validation, Production, Microbiology and Quality Assurance
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INTERNAL QUALITY AUDIT CHECKLIST FOR
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PROCESS SIMULATION
Audit Report No.: 2021/QA/007 Audit Date: 21 and 22 SEP 2021
Audited Department: Validation, Production, Microbiology and Quality Assurance
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INTERNAL QUALITY AUDIT CHECKLIST FOR
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PROCESS SIMULATION
Audit Report No.: 2021/QA/007 Audit Date: 21 and 22 SEP 2021
Audited Department: Validation, Production, Microbiology and Quality Assurance
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PROCESS SIMULATION
Audit Report No.: 2021/QA/007 Audit Date: 21 and 22 SEP 2021
Audited Department: Validation, Production, Microbiology and Quality Assurance
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INTERNAL QUALITY AUDIT CHECKLIST FOR
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PROCESS SIMULATION
Audit Report No.: 2021/QA/007 Audit Date: 21 and 22 SEP 2021
Audited Department: Validation, Production, Microbiology and Quality Assurance
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INTERNAL QUALITY AUDIT CHECKLIST FOR
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PROCESS SIMULATION
Audit Report No.: 2021/QA/007 Audit Date: 21 and 22 SEP 2021
Audited Department: Validation, Production, Microbiology and Quality Assurance
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INTERNAL QUALITY AUDIT CHECKLIST FOR
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PROCESS SIMULATION
Audit Report No.: 2021/QA/007 Audit Date: 21 and 22 SEP 2021
Audited Department: Validation, Production, Microbiology and Quality Assurance
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