Ab

Dhaka, Bangladesh

Standard Operating Procedure (SOP)

TITLE
PROCEDURE FOR CARRYING OUT PROCESS VALIDATION
Rev. Issue Date: Superseded
Document No. Page
No. Effective Date:
Rev. No. 09 1 of 24
SOP/ACME-VAL/ 10 Review Due:
068
DISTRIBUTION
1. Head of Quality Operations(SDU, BLS, HSU And GNU, CPU, PNU)
2. Head of Production Operation
3. Head of Global Regulatory Affairs
4. Head of Quality Assurance (GNU, SDU & BLS, CPU, HSU, PNU)
5. Head of Quality Control (SDU, CPU, BLS, HSU, PNU)
6. Head of Unit Production (GNU, SDU, CPU, BLS, BLS-Solid, HSU, PNU)
7. Head of Microbiology
8. Head of FRD
9. Head of ARD
10. Head of RDQA
11. In-charge, Microbiology(SDU, CPU, BLS, HSU, PNU)
12. In- charge, Validation (PV)
13. Executive, Validation (PV)
14. Executive, FRD
15. Executive, QA (GNU, SDU, CPU, BLS, HSU, PNU)

Name Designation Signature Date

Prepared by Jarin Rahman Moromi Sr. Executive, Validation
Checked by Sanzida Chowdhury Manager, Validation
Checked by Md. Quamrul Hasan Sr. Manager, R&D

Checked by Jiban Chandra Das AGM, R&D

Checked by Md. Mahbubul Alam Sr. Manager, QA

Checked by Shah Sharfin Sr. Manager, QA
Mohammad Tarique AGM, Quality
Approved by
Nasim Operations
Approved by Dr. Md. Zahurul Hossain GM, Quality Operations
 Ab
Dhaka, Bangladesh

Standard Operating Procedure (SOP)

TITLE
PROCEDURE FOR CARRYING OUT PROCESS VALIDATION
Rev. Issue Date: Superseded
Document No. Page
No. Effective Date:
Rev. No. 09 2 of 24
SOP/ACME-VAL/068 10 Review Due:

1 PURPOSE
To describe the procedure for carrying out process validation activities of the product.

2 SCOPE
This procedure is applicable for all products manufactured at The ACME Laboratories Ltd.
Dhaka, Bangladesh.

3 RESPONSIBILITIES
3.1 Executive, R&D (FRD) is Responsible to –
3.1.1 Submit the Master Formula (MF) to QA (Where applicable).
3.1.2 Prepare process validation protocol and report of new product and existing product.
3.1.3 Execute PV batches as per protocol.
3.1.4 Prepare process verification protocol and report.
3.1.5 Join as a team member of continued/ongoing process verification.
3.2 Manager, R&D (FRD)/Nominee is Responsible to –
3.2.1 Check process validation/verification protocol and report.
3.2.2 Ensure proper execution of PV batches.
3.2.3 Review continued/ongoing process verification calendar.
3.2.4 Check thecontinued/ongoing process verification protocol and report.
3.3 Executive, Production is Responsible to–
3.3.1 Prepare the Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR) based
on corresponding master formula.
3.3.2 Execute PV batches as per protocol.
3.3.3 Provide all supports for execution of PV batches.
3.4 Head of Production/Nominee is Responsible to –
3.4.1 Check process validation/verification protocol and report.
3.4.2 Review the continued/ongoing process verification calendar.
3.4.3 Check the continued/ongoing process verification protocol & report.
3.5 Executive, Validation is Responsible to –
3.5.1 Prepare continued/ongoing process verification calendar.

Name Designation Signature Date

Checked by Sanzida Chowdhury Manager, Validation
 Ab
Dhaka, Bangladesh

Standard Operating Procedure (SOP)

TITLE
PROCEDURE FOR CARRYING OUT PROCESS VALIDATION
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3.5.2 Check the process validation/verification report submitted by R&D.
3.5.3 Assist all QMS issues related to Validation Batches.
3.5.4 Prepare the checklist for process validation activities (Appendix-A).
3.5.5 Prepare and verify the checklist for process validation file (Appendix- B).
3.5.6 Prepare packaging validation/verification protocol & reports of existing products.
3.5.7 Prepare continued/ongoing process verification protocol and reports.
3.6 In-charge, Validation/Nominee is Responsible to –
3.6.1 Check process validation/verification protocol and report.
3.6.2 Ensure proper execution of process validation protocol.
3.6.3 Check the continued/ongoing process verification protocol & report.
3.6.4 Review and follow up continued process verification calendar.
3.7 Executive, QA is Responsible to –
3.7.1 Maintain the protocol issuing and tracking system.
3.7.2 Maintain the PV file tracking system in archive.
3.7.3 Perform sampling as per protocol.
3.7.4 Collection of data for continued process verification.
3.7.5 Handle of any Deviation, OOS/OOT related to Validation batches.
3.8 Executive, QC/Microbiology is Responsible to –
3.8.1 Perform the analysis of process validation and process verification batches.
3.9 Head of QC/Microbiology/Nominee is Responsible to –
3.9.1 Check the process validation/verification protocol.
3.10 Head of GRA/Nominee is Responsible to –
3.10.1 Check the risk assessment for related to product validation.
3.10.2 Check the process validation protocol & report (Where required).
3.10.3 Check the continued/ongoing process verification protocol & report (Where required).
3.11 Head of QA/Nominee is Responsible to –
3.11.1 Approve the process validation/verification protocol and report.
3.11.2 Approve the continued/ongoing process verification Calendar.
3.11.3 Approve the continued/ongoing process verification protocol &report.
3.11.4 Take decision to precede PV after checking prerequisite.

Name Designation Signature Date

Checked by Sanzida Chowdhury Manager, Validation
 Ab
Dhaka, Bangladesh

Standard Operating Procedure (SOP)

TITLE
PROCEDURE FOR CARRYING OUT PROCESS VALIDATION
Rev. Issue Date: Superseded
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4 TRAINING REQUIREMENTS
Training is required for Executive and above of Validation, QA, R&D, Production, QC,
Microbiology, GRA and Engineering.

5 ASSOCIATED DOCUMENTS
Preparation, Review and Approval of Process Validation : SOP/ACME-VAL/067
Protocoland Report
Procedure for New Product Development : SOP/ACME-R&D/002
Preparation, Review, & Distribution of Master Formulation (MF),
: SOP/ACME-R&D/012
Batch Manufacturing Record& Batch Packaging Record (BPR)

Documentation Control and Management : SOP/ACME-QA/002

Issue, Receive, Check, Compilation and Review of Batch : SOP/ACME-QA/021
Document
Management of Deviation : SOP/ACME-QA/023

Handling of Out of Specification/ Out of Trend Test Results : SOP/ACME-QC/007

Reporting of Incidents in Quality Control Laboratory : SOP/ACME-QC/008

Preparation, Review and Approval of Process Optimization : SOP/ACME-R&D/001
Protocol and Report
Quality Risk Management : SOP/ACME-QA/007

Stability Study Management : SOP/SBU-QC/035

6 ABBREVIATIONS AND DEFINITIONS

BLS : BFS, Liquid & Semi-Solid Unit
BMR : Batch Manufacturing Record
CPV : Continued Process Verification
CQA : Critical Quality Attribute
CPP : Critical Process Parameter
CPU : Cephalosporin Unit
CMA : Critical Material Attribute
FRD : Formulation Research and Development
GNU : General Unit
HSU : Hormone & Steroid Unit

Name Designation Signature Date

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Standard Operating Procedure (SOP)

TITLE
PROCEDURE FOR CARRYING OUT PROCESS VALIDATION
Rev. Issue Date: Superseded
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HVAC : Heating, Ventilation & Air Conditioning
IPQA : In Process Quality Assurance
IQ : Installation Qualification
LIR : Laboratory Incident Report.
MF : Master Formula
MIC : Microbiology
OOS : Out of Specification
OOT : Out of Trend
OQ : Operational Qualification
PNU : Penicillin Unit
PO : Process Optimization
PQ : Performance Qualification
PV : Process Validation
QA : Quality Assurance
QC : Quality Control
QO : Quality Operations
QMS : Quality Management System
R&D : Research & Development
SDU : Solid Dosages Unit

Process Validation Protocol:

A document stating how validation will be conducted, including test parameters, product
characteristics, manufacturing equipment, and decision points on what constitutes acceptable
test results.
Process Validation:
Process validation is established documented evidence which provides a high degree of
assurance that a specific process will consistently produce a product meeting its
predetermined specifications and quality attributes.
ProspectiveValidation:
Prospective validation is carried out during the development stage by means of a risk analysis
of the production process, which is broken down into individual steps: these are then
Name Designation Signature Date
Checked by Sanzida Chowdhury Manager, Validation
 Ab
Dhaka, Bangladesh

Standard Operating Procedure (SOP)

TITLE
PROCEDURE FOR CARRYING OUT PROCESS VALIDATION
Rev. Issue Date: Superseded
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evaluated on the basis of past experience to determine whether they might lead to critical
situations.
Concurrent Validation:
Concurrent validation is carried out during normal routine production of products intended for
sale or supply. A process where current production batches are used to monitor processing
parameters. It gives assurance of the present batch being studied and offers assurance
regarding consistency of quality from batch to batch.
Revalidation:
Revalidation is needed to ensure that changes in the process and or in the process
environment or any other significant changes, which adversely affect process characteristics
and product quality.
Process Verification:
Confirmation by examination and provision of objective evidence that the specified
requirements have been fulfilled. Process verification will be denoted wherespecific one batch
process validation is required.
Continued/Ongoing Process Verification:
Assuring that during routine production, the processremains in a state of control.
Partial Validation:
Partial validation is performed on a previously-validated method that has undergone minor
modification or changes in equipment, process, specification etc.
Packaging Validation:
To confirm that the resulting product from a specified packaging process consistently
conforms to product attributes & requirements.
CriticalProcess Parameters (CPP):
A Critical Process Parameter (CPP) is a term used in pharmaceutical production for process
variables which have an impact on a critical quality attribute (CQA) to ensure the drug product
obtains the desired quality.
CriticalQuality Attribute (CQA):
A critical quality attribute is a physical, chemical, biological, or microbiological property or
characteristic that should be within an appropriate limit, range, or distribution to ensure the
desired product quality.

Name Designation Signature Date

Checked by Sanzida Chowdhury Manager, Validation
 Ab
Dhaka, Bangladesh

Standard Operating Procedure (SOP)

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PROCEDURE FOR CARRYING OUT PROCESS VALIDATION
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Critical Material Attribute(CMA):
A critical material attribute (CMA) is a physical or chemical or microbiological property which
variability has an impact on the critical quality attribute and therefore it should be monitored or
controlled to ensure the desired product quality.

7 PRECAUTION
7.1 Only the trained personnel on respective SOPs are eligible to be involved in the process
validation activities.
7.2 Raw and packaging materials availability must be ensured by user department before
execution of PV batches.

8 PROCEDURE
8.1 Process Validation activities will be performed in three stages:
8.1.1 Stage-1: Process Design
8.1.1.1 Raise a change control for introduction of new product based on product development study.
8.1.1.2 Define CQA, CPP&CMA through risk assessment, during product development.
8.1.1.3 Run scale up/ process optimization batches (as per requirement) following SOP for Carry out
Process Optimization Batch in GMP Facility (SOP/ACME-R&D/006).
8.1.1.4 After successful completion of Scale up/ Process optimization batch proceed for Stage-2:
Process Qualification/ Process Validation.
8.1.2 Stage-2: Process Qualification/ Process Validation
8.1.2.1 Prepare the PV BMR, BPR and Protocolbased on corresponding master formula and scale
up/ process optimization report if PO is done.
8.1.2.2 Preparethe check list for process validation activities (Appendix-A) in case of new product,
transfer product & full validation/ re-validation.
8.1.2.3 Take decision to proceed as per Appendix-A.
8.1.2.4 Provide training on the approved protocol as per Appendix-A of PV Protocol before
execution of PV batches.
8.1.2.5 Issue the approved BMR & BPR according to SOP: SOP/ACME-QA/021.
8.1.2.6 Issue the approved protocol and relevant appendices to production by stamping the QA
issued seal on the top of the first page of protocol. Stamp the batch number on first page of

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Standard Operating Procedure (SOP)

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Appendix-B, Appendix-C and Appendix-D of the protocol.Appendix-A (Training Status) of
protocol will be issued only before execution of 1st PV batch.
8.1.2.7 Carry out process validation activities in accordance with written approved protocol, BMR
andBPR.
8.1.2.8 Take at least three consecutive batches for process validation for the product. If any one
batch is unsuccessful due to accidental case (e.g. Spoilage, machine problem, human
error etc.) not related to process parameter, then consider immediate next batch (es) as
consecutive batch (es) for PVthrough proper justification or QMS tools.
8.1.2.9 Pre-Requisite for PV Activities
8.1.2.9.1 Check the IQ, OQ & PQ (can be covered in OQ) for all critical process equipment as
specified for that process.
8.1.2.9.2 Check the calibration status of the critical instruments which will be used in process
validation activity.
8.1.2.9.3 Check the availability of process optimization report after successful completion of
process optimization batches where applicable.
8.1.2.9.4 Check the QA approved list of SOP’s for manufacturing/analysis.
8.1.2.9.5 Check the change control and CAPA status for process validation.
8.1.2.9.6 Check the approved master formula, protocol, BMR and BPR before execution of process
validation batches.
8.1.2.9.7 Check the approved vendor status of raw materials which will be used in process
validation batches.
8.1.2.9.8 Check the approved analytical methods (according to Pharmacopoeia monograph or in-
house developed) for raw materials, intermediates and finished products before execution
of PV.
8.1.2.9.9 Check the approved specification & analytical report sheet of intermediate, bulk & finished
product.
8.1.2.9.10 Provide training on PV protocol before execution of PV batch for new technology & if
required decided by Manager, R&D.
8.1.2.10 Compilation of Process Validation File
8.1.2.10.1 Compile process validation file of each product with following contents as per Appendix-
B.

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Standard Operating Procedure (SOP)

TITLE
PROCEDURE FOR CARRYING OUT PROCESS VALIDATION
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8.1.2.10.2 Process Validation Report
 Process Validation Summary Report
 Summary of Assessment
- Summary report on test results
- Summary report on critical process parameters
- Summary report on non-critical process parameters
8.1.2.10.3 Approved master copy of protocol for process validation.
8.1.2.10.4 Executed protocol for process validation.
8.1.2.10.5 Training attendance on protocol (If required).
8.1.2.10.6 Batch records including BMR, BPR and analytical test report.
8.1.2.10.7 Checklist for process validation activities.
8.1.2.10.8 Prepare and verifythe check list for process validation file (APPENDIX-B) and finish
compilation of PV file and archive in QA.
8.1.3 Stage-3: Continued Process Verification (CPV)
8.1.3.1 Prepare Continued Process Verification calendar within 2nd quarter of every year.
8.1.3.2 During calendar preparation consider Regulatory or other requirements, Deviation,
OOS/OOT, Customer Complaint, Change Control, CAPA, PQR, Rejection, Recall, Process
Validation and other QMS events etc.
8.1.3.3 Initiate continued process verification study as per the calendar.
8.1.3.4 Continued Process Verification protocol to be written.
8.1.3.5 Collect protocol number from QA for specific product as per SOP/ACME-QA/002.
8.1.3.6 Write the protocol for specific product after receiving the protocol number.
8.1.3.7 A monitoring plan will be included considering CQA/ CPP during continued process
verification study.
8.1.3.8 CPV monitoring will be performed in 3 years frequency considering minimum 20 commercial
batches for specific product/as per specific requirement.
8.1.3.9 Depending on the collected data, continued process verification summary report will be
prepared.
8.1.3.10 Recommendation & CAPA (if required) will be mentioned in summary report for process
improvement.

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Standard Operating Procedure (SOP)

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8.1.3.11 If any trouble shooting/change/deviation/OOS/OOT/process validation occurred during CPV,
decision will be taken by QA/QO head whether to continue or discontinue the CPV study.
8.1.4 Revalidation
8.1.4.1 Prepare the process validation protocol.
8.1.4.2 Prepare the check list for process validation activities (Appendix-A).
8.1.4.3 Take decision to proceed or not to proceed for process validation.
8.1.4.4 For re-validation, prepare BMR/BPR for the specific stage in which change (s) is to be done
(e.g. If compression machine is changed, then core & coating stage is considered for re-
validation. Due to this change only the core BMR will be affected, so only the core BMR will
be revised for process validation, not coating BMR).
8.1.4.5 Issue the commercial/existing BMR and BPR according to the SOP: SOP/ACME-QA/021
additionally stamp the “PROCESS VALIDATION” or “PROCESS VERIFICATION” seal on
the center of the top of first page of BMR/BPR.
8.1.4.6 Issue the approved protocol following the same procedure mentioned in sub-section 8.1.2.6.
8.1.4.7 Compile the PV file following the same procedure mentioned in the sub-section 8.1.2.10.
8.1.4.8 Perform revalidation in case of changes mentioned in the below table (but not limited to)-
Sl. Type of Change Validation (Partial or Full)/Verification
No.
1. Scale Up/Scale Down Process Validation/ Process Verification*
2. Formulation Process Validation/ Process Verification*
3. Manufacturing Site Process Validation
Full validation of any one batch size of a
Multiple Batch Size
product/Verification*
Only one strength will be fully validated and
based on that data, other strength (s) will be
Source of API

Different Strengths & Dose

considered as validated for that respective
4. Proportional
source/Each strength will be verified.*

One strength will be fully validated, after that

Different Strengths & Not Dose other strength (s) will be proceed for one
Proportional batch verification of that respective source.

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Standard Operating Procedure (SOP)

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Sl. Type of Change Validation (Partial or Full)/Verification
No.
Process Validation/ Verification/Bracketing
5. Source of Major/Functional Excipients
Approach*
Equipment

6. a) If time limit is important Process Validation

b) Same model, same working

principle, same parameter & ProcessVerification/Bracketing Approach*
Equipment (Cont.)

batch size is not important.

c) Different model, different

working principle, Different
parameter & batch size is Partial validation
important. Process only
related to changed equipment.

7. Process Partial validation/ full Validation/Verification*

8. Specification of finished product Partial validation/ full Validation/Verification*

Packaging validation/ Verification/Bracketing

9. Primary packaging material
Approach*

10. Packaging mode Packaging validation/ Verification*

*Validation (Partial or Full) /Verification/ Bracketing Approachrequirement will be decided based on

the risk assessment, based on area & effect of change.Risk Assessment will be performed as per
SOP no. SOP/ACME-QA/007.

8.1.4.9 Consider the area in case of change of equipment, process & specification as mentioned in
the below table (but not limited to)-

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Standard Operating Procedure (SOP)

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Sl.
Type of Change Area will be considered for validation/verification
No.
1. Solid Dosages Form
Equipment category Tablet Capsule PFS/Sachet
Granulation/
Granulation,
Pelletization,
Granulation Suite Blending, Core & N/A
Blending &
Coating stage
Encapsulation stage
Blending &
Blending, Core & Blending &
Blender / Bin Size Encapsulation
Coating stage Encapsulation Stage
Stage

Compression Machine/
Encapsulation Machine/ Core & Coating
Encapsulation stage
Bottle or Sachet Filling stage Filling Stage
Machine
Equipment

Coating Machine Coating stage N/A N/A

Primary Primary packaging

Blister/Strip Machine N/A
packaging stage stage

Oral Liquid/ Semi-Solid/Sterile Line

Equipment Category Oral Liquid Semi solid Sterile
Melting, Mixing and
Filling Sealing
Processing
Stage/Gelatin Manufacturing
Vessel/Mixing Vessel/ Mixing and Filling
Preparation, and Filling
Vacuum Emulsifier/ Sealing Stage
Medicine Sealing Stage
Gelatin Melting Tank
Preparation and
Encapsulation Stage
Filling & Sealing Filling Sealing Filling Sealing Filling Sealing
Machine/Encapsulation Stage Stage/Encapsulation Stage

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Standard Operating Procedure (SOP)

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Sl.
Type of Change Area will be considered for validation/verification
No.
Machine Stage
MDI/DPI
Equipment Category MDI DPI
Equipment (Cont.)

Mixing and Filling Sealing

Manufacturing Vessel N/A
1. Stage
Blending and Filling
Bin Blender N/A
Sealing Stage
Filling & Sealing Machine Filling Sealing Stage Filling Sealing Stage
2. Solid Dosages Form

Change Process Tablet Capsule PFS/Sachet

Granulation,
Paste preparation Blending, Core & N/A N/A
Coating stage

Granulation,
Granulation Blending, Core & N/A N/A
Coating stage
Blending,
Blending, Core & Blending &
Blending Filling &
Coating Stage Encapsulation Stage
Sealing

Coating Coating Stage N/A N/A

Oral Liquid/ Semi-Solid/Sterile Line

Change Process Oral Liquid Semi solid Sterile

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Sl.
Type of Change Area will be considered for validation/verification
No.
P Syrup
r Syrup/ Melting, Mixing & Filling
Preparation/Suspension
o Suspension Sealing Stage/Gelatin Manufacturing
Preparation/Solution
c Preparation & Preparation, Medicine and Filling
preparation/ Melting
e Filling Sealing Preparation and Filling Sealing Stage
/Mixing/Gelatin
s Stage Sealing Stage.
Preparation
s
MDI/DPI
Process (Cont.)

Change process MDI DPI

2.
Mixing and Filling Sealing
Mixing Mixing and Filling Stage
Stage

3. Solid Dosages Form

Specification Tablet Capsule PFS/Sachet

Hardness, Thickness & Core, Coating &

N/A N/A
Diameter of Core Tablet. Primary Stage

Hardness, Thickness &

Coating & Primary
Diameter of Coated N/A N/A
Stage
Tablet.

Semi Solid Sterile

Specification Oral Liquid
Product Product
Syrup/Suspension
Preparation
Viscosity N/A N/A
and Filling Sealing
Stage
Average Filling Volume Filling Sealing Stage Filling Sealing Filling Sealing
Stage Stage

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Standard Operating Procedure (SOP)

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Sl.
Type of Change Area will be considered for validation/verification
No.
S MDI/DPI
p Specification MDI DPI
e
c
i
f
i
Filling Sealing
c Average Filling Weight Filling Sealing Stage
Stage
a
t
i
o
n

9 REFERENCES
9.1 Rules and Guidance of Pharmaceutical Manufacturers and Distributors; Annex 15:
Qualification and Validation.
9.2 WHO Technical Report Series No. 1019, WHO Expert Committee on Specifications for
Pharmaceutical Preparations Fifty-Third Report.
9.3 ICH Guideline [ICH Q8].
9.4 FDA: Guidance for Industry (Process Validation: General Principles and Practices).

10 APPENDICES
A. CHECK LIST FOR PROCESS VALIDATION ACTIVITIES (FORMAT).
B. CHECK LIST FOR PROCESS VALIDATION FILE (FORMAT).
C. CONTINUED/ONGOING PROCESS VERIFICATION CALENDAR (FORMAT).
D. PROCESS VALIDATION FLOW CHART.

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11 CHANGE HISTORY
DATE REVISION DESCRIPTION OF CHANGE
24/06/23 10 1. Distribution list has been updated.
2. Responsibilities have been modified.
3. Training requirements have been modified.
4. Associated documents, abbreviations and definitions have been
updated.
5. Precautions have been revised.
6. Procedure 8.1.1.2, 8.1.2.2, 8.1.2.3, 8.1.2.6 and 8.1.2.8have been
modified.
7. Procedure of previous version 8.1.2.7 has been omitted.
8. Procedure 8.1.2.9.8has been modified.
9. Procedure 8.1.2.10 has been revised.
10. Procedure 8.1.2.11 has beenomitted.
11. Procedure 8.1.3.7 has beenomitted.
12. Procedure 8.1.4.2 &8.1.4.8 have beenmodified.
13. Reference 9.5 has been omitted.
14. Appendix-A and Appendix-B have been modified.
15. Appendix-D, Appendix-E and Appendix-Fhave beenomitted.
16. Content of Appendix-D has been changed and Process Validation
Flow Chart has been added as Appendix-D.
17. Change control reference no. CCR/BLS-VAL/23/006.

08/05/22 09 1. Distribution list has been updated.

2. Responsibilities have been modified
3. Associated documents have been revised
4. Abbreviations and definitions have been revised and modified.
5. Procedure 8.1.1&8.1.3 have been newly added.
6. Existing content of 8.1 to 8.12 has been included in 8.1.2 (Process
Qualification/Process Validation).
7. Procedure 8.1.4 has been modified and rearranged.

Name Designation Signature Date

Checked by Sanzida Chowdhury Manager, Validation
 Ab
Dhaka, Bangladesh

Standard Operating Procedure (SOP)

TITLE
PROCEDURE FOR CARRYING OUT PROCESS VALIDATION
Rev. Issue Date: Superseded
Document No. Page
No. Effective Date:
Rev. No. 09 17 of 24
SOP/ACME-VAL/068 10 Review Due:
DATE REVISION DESCRIPTION OF CHANGE
8. Appendix-A, Appendix-B, Appendix-C and Appendix-D have been
modified.
9. Content of Appendix-F has been changedand Process Validation
Flow Chart has been added as Appendix-G.
Change control reference no. DCCR/BLS-VAL/22/014.

08/07/21 08 1. Distribution list has been updated.

2. Document number has been changed from SOP/QA/009 to
SOP/ACME-VAL/068.
3. Responsibilities of PD have been revised as FRD in overall SOP.
4. Training requirements and references have been newly added.
5. Associated documents have been revised.
6. Abbreviations and definitions have been revised and modified.
7. Procedure 8.4, 8.5, 8.6 & 8.7 have been modified.
8. Procedure 8.10 has been modified and rearranged.
9. Procedure 8.11 has been modified and updated.
10. Procedure 8.13 for source validation has been excluded as it will
be covered in the sub section 8.14.8 under revalidation.
11. On-going process verification procedure number is revised as 8.13
and this procedure has been modified.
12. Revalidation procedure number is revised as 8.14 and this
procedure has been modified and the sub section 8.14.8 & 8.14.9
under revalidation has been modified and updated.
13. Reference 9.2 has been updated and 9.4 & 9.5 have been newly
added.
14. Appendix-A, Appendix-B, Appendix-C and Appendix-D have been
modified.
15. Appendix-E and Appendix-F have been newly added.
16. Change control reference no. CCR/BLS/21/358.

20/01/21 07 1. Distribution list has been updated.

Name Designation Signature Date
Checked by Sanzida Chowdhury Manager, Validation
 Ab
Dhaka, Bangladesh

Standard Operating Procedure (SOP)

TITLE
PROCEDURE FOR CARRYING OUT PROCESS VALIDATION
Rev. Issue Date: Superseded
Document No. Page
No. Effective Date:
Rev. No. 09 18 of 24
SOP/ACME-VAL/068 10 Review Due:
DATE REVISION DESCRIPTION OF CHANGE

2. Precaution 7.3 has been excluded and a new precaution has been
added in 7.5.
3. Responsibility 3.5 & 3.8 have been modified.
4. The procedures have been modified and updated [8.9, (8.11-
procedure 8.11 split into three points 8.11.1, 8.11.2 & 8.11.3),
8.14.2, 8.15.2 serial no. 4].
5. Procedures 8.15.4 & 8.15.5 have been newly added.
6. Reference 9.3 has been newly added.
7. In Appendix –A, option for specification & analytical report sheet
for intermediate, bulk & finished product has been added (Serial
No. 8).
8. In Appendix-B, option for ‘statically evaluation report of process
data’ has been included & option for ‘calibration status’ has been
excluded.
9. Change control reference no. CCR/SDU/19/655.

18/04/19 06 1. Distribution list has been updated.

2. New precautions have been added (7.4 & 7.5).
3. Responsibilities have been rearranged and updated and new
responsibility for QC has been added (3.6 & 3.8).
4. The procedures have been modified and updated (8.15.2 &
8.15.3).
5. New appendices have been added (Appendix-C & Appendix-D).
6. Procedure for ongoing process verification has been newly added
(8.14).
7. Team Formation for Process Validation has been excluded from
procedure.
8. Training requirement on PV protocol has been modified based on
new technology and decision provided by Manager, QA in

Name Designation Signature Date

Checked by Sanzida Chowdhury Manager, Validation
 Ab
Dhaka, Bangladesh

Standard Operating Procedure (SOP)

TITLE
PROCEDURE FOR CARRYING OUT PROCESS VALIDATION
Rev. Issue Date: Superseded
Document No. Page
No. Effective Date:
Rev. No. 09 19 of 24
SOP/ACME-VAL/068 10 Review Due:
DATE REVISION DESCRIPTION OF CHANGE
procedure.
9. New abbreviation and definition have been added.
10. New associated documents have been added.
11. Change control reference no: CCR/SDU/19/166.

16/10/17 05 1. Distribution list has been modified.

2. Training requirements and references have been newly added.
3. New precautions have been added.
4. Associated documents have been revised.
5. Responsibilities have been revised and updated.
6. Abbreviations and definitions have been revised and modified.
7. The entire procedure have been modified and updated.
8. New appendices have been added (Appendix-A & Appendix-B).
9. SOP format has been changed.
10. SOP number has been changed from 07-04-QA-008 to
SOP/QA/009.
11. Procedure for source validation and revalidation has been newly
added.
12. Process validation report format has been changed.
13. Change control reference no: CCR/SDU/17/362.

20/09/16 04 1. Routine review.

09/09/14 03 1. Company name and logo has been changed.

2. Distribution list has been revised.
3. “Raised by” author has been changed.
4. Purpose & scope have been modified.
5. Associated documents have been included.
6. Responsibilities have been modified and changed.
7. Precaution has been included.
8. Procedure has been modified and rearranged.

Name Designation Signature Date

Checked by Sanzida Chowdhury Manager, Validation
 Ab
Dhaka, Bangladesh

Standard Operating Procedure (SOP)

TITLE
PROCEDURE FOR CARRYING OUT PROCESS VALIDATION
Rev. Issue Date: Superseded
Document No. Page
No. Effective Date:
Rev. No. 09 20 of 24
SOP/ACME-VAL/068 10 Review Due:
DATE REVISION DESCRIPTION OF CHANGE

20/05/11 01 1. New SOP.

Name Designation Signature Date

Checked by Sanzida Chowdhury Manager, Validation