STANDARD OPERATING PROCEDURE

Department: Quality Assurance SOP No.:

Title: Process Validation Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

1.0 OBJECTIVE:
To lay down a Procedure for Process Validation.

2.0 SCOPE:
This SOP is applicable to all products manufactured at ……………………

3.0 RESPONSIBILITY:
QA (Officer/Executive): Preparation, Distribution (to Respective Department), Revision, Retrieval and
Destruction of this SOP.
QA Manager: Review, Approval, Training and effective implementation of this SOP in all the
applicable areas.
Production & QC: Effective implementation of the Procedure

4.0 ACCOUNTABILITY:
Head QA: Approval of this SOP & ensure Training and effective Implementation of SOP.

5.0 DEFINITION:
Process Validation is documented evidence which provides a high degree of assurance that a specific
process will consistently result in a product that meets its predetermined specifications and quality
characteristics”.

6.0 PROCEDURE:
6.1 TYPES OF PROCESS VALIDATION:
6.1.1 PROSPECTIVE PROCESS VALIDATION:
 “Validation carried out during development stage or before the Commercial Production”
6.1.2 CONCURRENT PROCESS VALIDATION:
 “Validation carried out during routine production of products intended for sale”.
 STANDARD OPERATING PROCEDURE
Department: Quality Assurance SOP No.:
Title: Process Validation Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

6.2 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.
6.3 VALIDATION BATCH:
 Validation Batch is a Batch Manufactured and tested to verify the Critical Parameters &
Manufacturing Process controls are adequate.
6.4 IN-PROCESS SAMPLING:
 Process of collecting a representative sample by selecting units deliberately from various
identified locations within a Lot or Batch, or from various phases or periods of a process to obtain
a sample dosage unit that specifically targets locations throughout the Compression / Filling
Operation that have a higher risk of producing failing results in the Finished Product Uniformity
of content.
6.5 APPROACH TO PROCESS VALIDATION:
6.5.1 Two Basic approaches to process validation are- one based on validation carried out during
development stage or before the Commercial Production (Prospective Validation), and second
based on validation carried out during routine production of products intended for sale
(Concurrent Validation).
6.5.2 Whenever possible, Prospective Validation is preferred. Retrospective Validation is no longer
encouraged and is, in any case, not applicable to the manufacturing of Sterile Products.
6.5.3 Both Prospective and Concurrent Validation, may include:
 Extensive Product Testing, which may involve extensive sample testing (with the estimation
of confidence limits for individual results) and the demonstration of intra- and inter-batch
homogeneity;
 Challenge/Worst Case Tests, which determine the Robustness of the Process;
 Control of Process Parameters being monitored during normal production runs to obtain
additional information on the reliability of the process.
 STANDARD OPERATING PROCEDURE
Department: Quality Assurance SOP No.:
Title: Process Validation Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

6.6 VALIDATION/RE-VALIDATION SHALL BE CARRIED OUT IN FOLLOWING CASES:

 Introduction of New Product
 Periodic Validation
 Change in the Batch Size of the Product
 Change(s) in the actual process that may affect quality or its validation status.
 Change(s) in the product design which affects the process i.e. Change in Critical Process
Parameters, Optimization Batch (es) shall be planned to evaluate such parameters and their
impact on process and product quality.
 Change in Critical Equipment’s.
 Appearance of negative trend of product quality.
 Change initiated due to Market Complaints, Deviations on Shop Floor, Annual Product Review
and Stability Studies etc.
 Physical characters (Particle Size, Bulk Density, Moisture Content etc) or Excipients having
potential impact on process.
 Transfer of process from one facility to another.
 Change in the application of the process.
 Change in Critical Formulation Component i.e. Raw Material Quantity.
 Change in manufacturer or vendor of Active Pharmaceutical Ingredient (vendor under
development).
6.6.1 The need for revalidation should be evaluated and documented. This evaluation should
include historical results from Quality Indicators, Product Changes, Process Changes, Changes in
External Requirements (regulations or standards) and other such circumstances.
6.7 PREPARATION OF A NEW PROCESS VALIDATION PROTOCOL AND REPORT:
6.7.1 The Process Validation Protocol and Report shall be written in English Language only by using
Microsoft Word typing.
6.7.2 Process Validation Protocol and Report shall be initiated by QA Department. The person directly
involved in the Process Validation Activity shall initiate the New Process Validation Protocol and
Report / Revision of Process Validation Protocol and Report.
 STANDARD OPERATING PROCEDURE
Department: Quality Assurance SOP No.:
Title: Process Validation Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

6.7.3 Initiator shall check the completeness of draft Process Validation Protocol and Report and send
the hardcopy to the different Departmental Heads (Head-Production, Quality Control &
Engineering) for review.
6.7.4 Draft Process Validation Protocol and Report hardcopy shall be send to customer for review (if
required).
6.7.5 On receipt of the comments (if any), the same shall be reviewed and incorporated in the Process
Validation Protocol and Report after discussion with Head-QA.
6.7.6 The draft Process Validation Protocol and Report after completion of checking and incorporation
of comments or suggestions as agreed, shall be destroyed, this shall be done in concerned
Originating Department.
6.7.7 Master Copies of all Process Validation Protocol and Report shall be printed in QA Department
only.
6.7.8 No manual correction shall be made in Approved Copy (Master / Controlled Copy).
6.7.9 Procedure for Preparation, Validation/Qualification Protocol and Report is given in SOP.
6.7.10 Storage of Process Validation Protocol and Report (Master Copy):
All Master Copy of Approved Process Validation Protocol and Report shall be stored in QA
Department.
 STANDARD OPERATING PROCEDURE
Department: Quality Assurance SOP No.:
Title: Process Validation Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

6.8 PROCESS VALIDATION FLOW:

VALIDATION
PROTOCOL
PREPARATION

BMR/BPR, MFR, SPECIFICATION,

STP, SOP,
VALIDATION TEAM
SAMPLING PROCEDURE,
PROTOCOL
PLANNING

INPUT REVIEW
RECORDS

CHECK QUALIFICATION OF
EQUIPMENT, ENVIRONMENT,
UTILITY, RM & PM

EXECUTION OF ACTIVITY

DATA COLLECTION & REVIEW

COMPLIANCE OF ACCEPTANCE
CRITERIA

REPORT REVIEW

APPROVAL
 STANDARD OPERATING PROCEDURE
Department: Quality Assurance SOP No.:
Title: Process Validation Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

6.9 RESPONSIBILITY & ACTIVITY FLOW FOR PROCESS VALIDATION:

ACTIVITY

PRODUCTION QUALITY ENGINEERING QUALITY CONTROL

ASSURANCE

PROTOCOL PROTOCOL
PROTOCOL PROTOCOL & REVIEW
REPORT REVIEW
REVIEW
PREPARATION /
REVIEW
VALIDATION
SUPPORT SAMPLE
SUPPORT FOR SERVICES ANALYSIS
VALIDATION PROTOCOL
ACTIVITY APPROVAL
RESULTS
SUBMISSION
PROTOCOL
TRAINING TO
VALIDATION VALIDATION REPORT
REPORT
EXECUTION TEAM REVIEW
REVIEW

MONITORING PROTOCOL
REPORT COMPLETENESS &
REVIEW TECHNICAL ACCURACY,
SAMPLING & EXECUTION
OF VALIDATION ACTIVITY

REPORT
REVIEW

REPORT
APPROVAL
 STANDARD OPERATING PROCEDURE
Department: Quality Assurance SOP No.:
Title: Process Validation Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

6.10 PROTOCOL DEVELOPMENT:

6.10.1 Identification of the process to be validated.
6.10.2 Identification of Product(s) to be manufactured using this process.
6.10.3 Objective and measurable criteria for a successful validation.
6.10.4 Length and duration of the validation.
6.10.5 Shifts, Operators, Equipment to be used in the process.
6.10.6 Identification of utilities for the Process Equipment and quality of the Utilities.
6.10.7 Identification of Operators and required Operator Qualification.
6.10.8 Complete description of the Process.
6.10.9 Relevant specifications that relate to the Product, Components, Manufacturing Materials, etc.
6.10.10 Any special controls or conditions to be placed on preceding processes during the Validation.
6.10.11 Process parameters to be monitored and methods for controlling and monitoring.
6.10.12 Product characteristics to be monitored and method for monitoring.
6.10.13 Any subjective criteria used to evaluate the product.
6.10.14 Definition of what constitutes Non-conformance for both measurable and subjective criteria.
6.10.15 Statistical methods for data collection and analysis.
6.10.16 Consideration of maintenance and repairs of Manufacturing Equipment.
6.10.17 Criteria for Revalidation.

6.11 LAYOUT OF PROCESS VALIDATION PROTOCOL AND REPORT:

All Process Validation Protocol and Report shall contain Header, Footer and Body. Format of Process
Validation Protocol and Report is given in SOP.
6.11.1 All pages shall contain Format No. in a Footer part.
6.11.2 All the points in the Process Validation Protocol and Report shall be numbered sequentially and
sub paragraph of the Process Validation Protocol and Report be also numbered sequentially with
an Incremental Number derived from the Heading Number.
6.11.3 Written Process Validation Protocol shall specify the procedures (and tests) to be conducted and
the data to be collected.
 STANDARD OPERATING PROCEDURE
Department: Quality Assurance SOP No.:
Title: Process Validation Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

6.11.4 The Protocol should specify a sufficient number of replicate process runs to demonstrate
Reproducibility and provide an Accurate Measure of Variability among Successive Runs.
6.11.5 The test conditions for these runs should encompass Upper and Lower Processing Limits and
Circumstances, including those within Standard Operating Procedures, which pose the greatest
chance of Process or Product Failure compared to ideal conditions.
6.11.6 Key Process Variables should be monitored and documented.
6.11.7 Analysis of the data collected from monitoring will establish the variability of process parameters
for individual runs and will establish whether or not the equipment and process controls are
adequate to assure that product specifications are met.
6.11.8 Trend in the process should be monitored to ensure the process remains within the established
parameters. When monitoring data on quality characteristics demonstrates a negative trend, the
cause should be investigated, corrective action may be taken and revalidation considered.
6.11.9 Any change in the Process and/or Product including changes in Procedures, Equipment, and
Personnel etc should be evaluated to determine the affects of those changes and the extent of
Revalidation considered.
6.11.10Various changes may occur in Raw materials and/or Processes, which are undetected, or
considered at the time to be inconsequential. These changes may cumulatively affect the
validation status of the process. Periodic Revalidation should be considered for these types of
processes.
6.12 PROCESS VALIDATION TEAM:
Members of the Validation Team shall include representatives from:
 Quality Assurance
 Production
 Quality Control
 Engineering
6.13 PROCESS VALIDATION FOR LIQUID INJECTIONS IN AMPOULES:
6.13.1 Critical Process Variables:
 STANDARD OPERATING PROCEDURE
Department: Quality Assurance SOP No.:
Title: Process Validation Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Following are the Critical Process Variables which are to be validated during Process Validation
but not limited to:
 Washing and Sterilization of Sterile Garments: Washing Time, Sterilization Time,
Sterilization Temperature Range, Sterilization Hold Time etc.
 Cleaning and Sterilization of Equipments: Washing Time, Sterilization Time, Sterilization
Temperature Range, Sterilization Hold Time etc.
 Preparation of Bulk Solution: Mixing Time, Mixing Speed, Process Time & Capacity of the
Mixing Vessel etc.
 Filtration of Bulk Solution: Pre & Post Integrity of Filters, Process Time etc.
 Ampoule Sterilization and Depyrogenation: Process Time, Conveyor Speed, Conveyor Start
Temperature, Sterilization Time, Sterilization Temperature Range Sterilization Hold Time etc.
 Empty Ampoules: Sterility, BET, Physical Observation etc.
 Filling and Sealing: Differential Pressure in Sterile Area, Temperature, Relative Humidity
Process Time, Machine Speed, Fill Volume, Hopper/Tank Level Qualification, Pressure
reading of Nitrogen, Sealing Inspection, Clarity, Leak Test etc.
 Visual Inspection of Filled Ampoules: Physical Defects i.e. Deformation, Black or White
Particles, Volume Variation, Clarity, Fibers etc.
 Packing: Packing Style, Quality and Quantity of Packing etc.
6.13.2 Sampling and Analysis Plan:
Following are the Sampling and Analysis Plan during Process Validation but not limited to:
 Preparation of Bulk Solution: Description, pH, Identification Assay, Weight/ml, Bioburden
etc.
 Filtration of Bulk Solution: Sterility etc.
 Ampoule Sterilization and Depyrogenation: Conveyor Start Temperature Conveyor Speed
Sterilization Hold Time etc
 Empty Ampoules: Sterility, BET, Physical Observation etc.
 Filling and Sealing: Extractable Volume, Description, Identification, Particulate Matter, pH
Assay, Sterility, BET etc.
 STANDARD OPERATING PROCEDURE
Department: Quality Assurance SOP No.:
Title: Process Validation Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

 Packing: As per Finished Product Specification

6.13.3 Sample Quantity:
Quantity of the Samples shall be withdrawn as per the quantity mentioned in the respective
Process Validation Protocol.
6.13.4 Sampling Location:
Samples shall be withdrawn as per the locations mentioned in the respective Process Validation
Protocol.
6.14 PROCESS VALIDATION FOR LIQUID INJECTIONS IN VIALS:
6.14.1 Critical Process Variables:
Following are the Critical Process Variables which are to be validated during Process
Validation but not limited to:
 Washing and Sterilization of Sterile Garments: Washing Time, Sterilization Time,
Sterilization Temperature Range, Sterilization Hold Time etc.
 Cleaning and Sterilization of Equipments: Washing Time, Sterilization Time, Sterilization
Temperature Range, Sterilization Hold Time etc.
 Preparation of Bulk Solution: Mixing Time, Mixing Speed, Process Time & Capacity of the
Mixing Vessel etc.
 Filtration of Bulk Solution: Pre & Post Integrity of Filters, Process Time etc.
 Washing & Sterilization of Rubber Bungs: Process Time, Sterilization Time, Sterilization
Temperature Range, Sterilization Hold Time etc.
 Sterilization of Aluminium Seals: Process Time, Sterilization Time, Sterilization
Temperature Range, Sterilization Hold Time etc.
 Washing & Sterilization of Vials: Process Time, Speed of Washing Machine, Pressure of
Water and Compressed Air, Conveyor Speed, Conveyor Start Temperature, Sterilization Time,
Sterilization Temperature Range Sterilization Hold Time etc.
 Filling and Sealing: Differential Pressure in Sterile Area, Temperature, Relative Humidity
Process Time, Machine Speed, Hopper/Tank Level Qualification, Fill Volume, Pressure
reading of Nitrogen, Sealing Inspection, Clarity, Leak Test etc.
 STANDARD OPERATING PROCEDURE
Department: Quality Assurance SOP No.:
Title: Process Validation Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

 Visual Inspection of Filled Vials: Physical Defects i.e. Deformation, Black or White
Particles, Volume Variation, Clarity, Fibers etc.
 Packing: Packing Style, Quality and Quantity of Packing including coding Quality etc.
6.14.2 Sampling and Analysis Plan:
Following are the Sampling and Analysis Plan during Process Validation but not limited to:
 Preparation of Bulk Solution: Description, pH, Identification Assay, Weight / ml, Bioburden
etc.
 Filtration of Bulk Solution: Sterility etc.
 Washing & Sterilization of Rubber Bungs: Sterility, Visible Observation, Bacterial
Endotoxin Test, Moisture Content etc.
 Sterilization of Aluminium Seals: Sterility, Visible Observation, Bacterial Endotoxin Test,
Bioburden etc.
 Washing & Sterilization of Vials: Clarity, Visible Observation, Sterility, Bacterial Endotoxin
Test etc.
 Filling and Sealing: Description, Sterility Test, Bacterial Endotoxin Test, Particulate Matter,
pH, Water Content, Assay, Identification, Extract Volume, Volume Variation etc.
 Packing: As per Finished Product Specification
6.14.3 Sample Quantity:
Quantity of the Samples shall be withdrawn as per the quantity mentioned in the respective
Process Validation Protocol.
6.14.4 Sampling Location:
Samples shall be withdrawn as per the locations mentioned in the respective Process Validation
Protocol.
6.15 PROCESS VALIDATION FOR THREE PIECE ( EYE / EAR DROPS):
6.15.1 Critical Process Variables:
Following are the Critical Process Variables which are to be validated during Process Validation
but not limited to:
 STANDARD OPERATING PROCEDURE
Department: Quality Assurance SOP No.:
Title: Process Validation Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

 Washing and Sterilization of Sterile Garments: Washing Time, Sterilization Time,

Sterilization Temperature Range, Sterilization Hold Time etc.
 Cleaning and Sterilization of Equipments: Washing Time, Sterilization Time, Sterilization
Temperature Range, Sterilization Hold Time etc.
 Preparation of Bulk Solution: Mixing Time, Mixing Speed, Process Time & Capacity of the
Mixing Vessel etc.
 Filtration of Bulk Solution: Pre & Post Integrity of Filters, Process Time etc.
 Formation of Empty LDPE Vials: Weight of Empty Vials, Presence of Foreign Particles,
Design of Empty Vials, Wall Thickness, Parison Temperature etc.
 Filling and Sealing: Process Time, Machine Speed, Hopper / Tank Level Qualification,
Extruder Temperature, Hydraulic Oil Level, Hydraulic Oil Temperature & Pressure, Chilled
Water Temperature & Pressure, Air Pressure etc.
 Sterilization of Filled and Sealed Vials: Process Time, Sterilization Hold Time, Sterilization
Temperature Range, Pressure Range during Sterilization etc.
 Leak Testing of the Filled Vials: Process Time, Vacuum Hold Time, Applied Vacuum etc.
 Visual Inspection of Filled Vials: Physical Defects i.e. Deformation, Tip Cut, Collar Cut,
Rough Surfaces, Scratches, Black or White Particles, Volume Variation etc.
 Packing: Packing Style, Quality and Quantity of Packing including Coding Quality etc.
6.15.2 Sampling and Analysis Plan:
Following are the Sampling and Analysis Plan during Process Validation but not limited to:
 Preparation of Bulk Solution: Description, pH, Identification Assay, Weight / ml, Bioburden
etc.
 Filtration of Bulk Solution: Sterility etc.
 Filling and Sealing: Description, Sterility Test, Bacterial Endotoxin Test, Particulate Matter,
pH, Water Content, Assay, Identification, Extract Volume, and Volume Variation etc.
 After Terminal Sterilization: Sterility
 Packing: As per Finished Product Specification.
6.15.3 Sample Quantity:
 STANDARD OPERATING PROCEDURE
Department: Quality Assurance SOP No.:
Title: Process Validation Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

Quantity of the Samples shall be withdrawn as per the quantity mentioned in the Respective
Process Validation Protocol.
6.15.4 Sampling Location:
Samples shall be withdrawn as per the locations mentioned in the respective Process Validation
Protocol.
6.16 PROCESS VALIDATION FOR DRY POWDER INJECTION:
6.16.1 Critical Process Variables:
Following are the Critical Process Variables which are to be validated during Process
Validation but not limited to:
 Washing and Sterilization of Sterile Garments: Washing Time, Sterilization Time,
Sterilization Temperature Range, Sterilization Hold Time etc.
 Cleaning and Sterilization of Equipments: Washing Time, Sterilization Time, Sterilization
Temperature Range, Sterilization Hold Time etc.
 Washing & Sterilization of Rubber Bungs: Process Time, Sterilization Time, Sterilization
Temperature Range, Sterilization Hold Time etc.
 Sterilization of Aluminium Seals: Process Time, Sterilization Time, Sterilization
Temperature Range, Sterilization Hold Time etc.
 Washing & Sterilization of Vials: Process Time, Speed of Washing Machine, Pressure of
Water and Compressed Air, Conveyor Speed, Conveyor Start Temperature, Sterilization Time,
Sterilization Temperature Range Sterilization Hold Time etc.
 Filling and Sealing: Differential Pressure in Sterile Area, Temperature, Relative Humidity
Process Time, Machine Speed, Hopper Level Qualification, Fill Weight, Pressure reading of
Nitrogen, Sealing Inspection, Clarity, Leak Test etc.
 Visual Inspection of Filled Vials: Physical Defects i.e. Deformation, Black or White
Particles, Weight Variation, Clarity, Fibers etc.
 Packing: Packing Style, Quality and Quantity of Packing including Coding Quality etc.
6.16.2 Sampling and Analysis Plan:
Following are the Sampling and Analysis Plan during Process Validation but not limited to:
 STANDARD OPERATING PROCEDURE
Department: Quality Assurance SOP No.:
Title: Process Validation Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

 Washing & Sterilization of Rubber Bungs: Sterility, Visible Observation, Bacterial

Endotoxin Test, Moisture Content etc.
 Sterilization of Aluminium Seals: Sterility, Visible Observation, Bacterial Endotoxin Test,
Bioburden etc.
 Washing & Sterilization of Vials: Clarity, Visible Observation, Sterility, Bacterial Endotoxin
Test etc.
 Filling and Sealing: Description, Identification, Constituted Solution, Particulate Matter,
Uniformity of Dosages Unit, pH, Water Content, Bacterial Endotoxin Test, Sterility Test,
Assay and Related Substances etc.
 Packing: As per Finished Product Specification
6.16.3 Sample Quantity:
Quantity of the Samples shall be withdrawn as per the quantity mentioned in the respective
Process Validation Protocol.
6.16.4 Sampling Location:
Samples shall be withdrawn as per the locations mentioned in the respective Process Validation
Protocol.
6.17 BATCH SIZE FOR PROCESS VALIDATION BATCHES:
6.17.1 Process Validation shall be performed on batches of Fixed Batch Size or Minimum and
Maximum Batch size can be taken for validation on the basis of equipment capacity.
6.18 PROCESS VALIDATION FOR NEW PRODUCT LAUNCHES:
Depending on the Product complexities and recommendation from F&D / Customer / Optimization
Batches may not be required. In such cases, if 1st Validation Batch is manufactured without any change in
Critical Process Parameters; it shall follow with next two Validation Batches. Otherwise 1 st Validation
Batch is considered as Optimization Batch followed by Three Validation Batches.
6.19 If any of the Process Validation Batch deviates to follow the recommended process parameters, the batch
is not considered as Process Validation Batch and further Three Batches shall be considered as Process
Validation Batch.
 STANDARD OPERATING PROCEDURE
Department: Quality Assurance SOP No.:
Title: Process Validation Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

6.20 The Validation Batches may be commercialized on the basis of satisfactory Stability Data (Three / Six
Month Accelerated Stability Study) for the product. However Stability Studies are continued and
reviewed periodically.

7.0 ABBREVIATIONS:
BET Bacterial End toxin Test
DQ Design Qualification
F&D Formulation & Development
LDPE Low Density Poly Ethylene
LOD Loss on Drying
Ltd. Limited
PM Packing Material
QA Quality Assurance
QC Quality Control
RH Relative Humidity
RM Raw Material
SS Stainless Steel
STP Standard Test Procedure

8.0 ANNEXURES:
Not applicable

9.0 DISTRIBUTION:
Controlled Copy No. 01 Head Quality Assurance
Controlled Copy No. 02 Head Quality Control
Controlled Copy No. 03 Head Production
Master Copy Quality Assurance Department
 STANDARD OPERATING PROCEDURE
Department: Quality Assurance SOP No.:
Title: Process Validation Effective Date:
Supersedes: Nil Review Date:
Issue Date: Page No.:

10.0 REFERENCES:
 USFDA CDER: Guidance for Industry Process Validation: General Principles and Practices
 Schedule-M
 Validation Master Plan
 PIC’s Guidelines
 SOP, Titled “PREPARATION OF VALIDATION/QUALIFICATION PROTOCOL AND
REPORT.

11.0 REVISION HISTORY:

Revision Change Details Reason of Effective Date Done By
No. Control No. of Changes changes
00 Not Applicable Not Applicable New SOP