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Standard Operating Procedure on Validation and Qualification Procedure for Facility, Utility, Equipment and Process

October 3, 2023

OBJECTIVE:

To lay down a procedure for the validation process in terms of evaluation, planning, qualification, re-qualification and management of validation documentation.

SCOPE:

This SOP is applicable to the validation and qualification of process facilities, utilities, equipment, analytical instruments, and computerized systems for use according to cGMP. Herein “System/Systems” will be used interchangeably as the collective name for process facilities, utilities, equipment, analytical instruments and computerized systems. In the context of GLP operations, this procedure applies only to computerized systems. This SOP is applicable to {COMPANY NAME} {COMPANY LOCATION}.

RESPONSIBILITY:

Validation Team/Project Sponsor/Owner (herein referred to as the User)

Users are responsible for ensuring that:

All Systems are validated in accordance with this procedure.

Validation documentation is prepared, reviewed, approved, reported and archived prior to utilization of the System for routine GMP/GLP operations.

They review and approve all validation documentation generated in support of the systems.

Signature definition: Validation has been carried out and documented according to the Validation Procedure SOP and all deviations have been recorded and resolved.

Technical Support

Depending on the type of the Qualification/Calibration, Technical Support may be provided by:

Technical experts within Organization (specialized systems, analytical instruments).

Engineering (facilities, utilities and equipment)

Information Systems (computerized systems)

Specialized system (A supplier).

A combination of the above (this should be decided during the Evaluation and Planning phase where the project/validation team is assembled).

The Technical support is responsible for delivering Validation Systems (i.e. ensuring that the design, construction, testing, installation and commissioning of Systems are adequately documented and controlled). Technical Support will review and approve validation documentation for Systems.

ACCOUNTABILITY:

QA Head shall be accountable for Approval, Training, Implementation and Execution of this SOP

PROCEDURE:

DEFINITIONS & TERMINOLOGY:

Protocol: A Protocol is a written set of instructions broader in scope than a Standard Operating Procedure (SOP).

System: Referred in this SOP means Facility / Equipment / Instrument or Utility.

Activity: Any monitoring or measuring or Qualification step.

Validation / Qualification: Documented act of proving that any Facility / Utility / Equipment / Instrument / System actually lead to expected results.

URS (User Requirement Specification): Document indicating User Requirements and Specifications of any Equipment / Utility / System, submitted to Vendor(s) to ensure that the Equipment / Utility / System meet the intended purpose.

Design Qualification (DQ): Documented verification that the proposed design of the Facilities, Systems and Equipment is suitable for intended purpose.

Installation Qualification (IQ): Documented verification that the Facilities, Systems and Equipment as installed or modified, comply with the approved design & the Manufacturer’s recommendation.

Operational Qualification (OQ): Documented verification that the Facilities, Systems and Equipment as installed or modified, perform as intended throughout the anticipated Operating Range & is operating consistently as per the established specification or design criteria.

Performance Qualification (PQ): Documented verification that the Facilities, Systems and Equipment as connected together, can perform effectively and reproducibly, to perform approved process and deliver product specification consistently.

Re-Qualification: Planned, periodic Qualification to prove that any Facility / Utility / Equipment/ Instrument / System actually are in validated state.

Modification: Any significant change which may alter the validated state of Facility / Utility / Equipment /Instrument / System.

Relocation: Change in location of any Utility, Equipment or System.

GENERAL GUIDELINES FOR PREPARATION & APPROVAL OF QUALIFICATION, VALIDATION PROTOCOL & REPORTS:

Protocols & Reports shall be written in English Language by using Microsoft Word typing.

Protocols & Reports shall be initiated by User Department / QA Department.

The person directly supervising the Process or Activity shall initiate New Protocols & Reports & Revision of Protocols & Reports.

Protocols & Reports shall be written after thorough understanding of the Process & Activity. The Initiator of the Protocols & Reports shall have adequate knowledge, Training and experience in the related Areas of activity.

All the points in the Protocol / Report shall be numbered sequentially and sub paragraph of the Protocol / Report be also numbered sequentially with an incremental number derived from the heading number. Bullets May be use for sub paragraph of Protocol / Report.

The User Requirement Specification (URS), Design Specification (DS) and Functional Specification (FS) shall be required for Tailor Made System only. For Standard System (like Standard Weighing Balance & HPLC, etc), URS is not essential, only Design, Installation, Operational & Performance Qualification (as applicable) shall be done.

Initiator shall check the completeness of draft Protocols & Reports and send the hardcopy to the Head of the Department for review.

The reviewer shall check the draft Protocols & Reports for accuracy of the subject matter, Logical Sequence of Process. On receipt of the comments (if any), in the Protocols & Reports if agreed.

Protocols & Reports shall have reference of related document such as Pharmacopoeia and Guidelines published by various Regulatory Authorities. Wherever necessary illustrations and drawing shall be indicated to provide better clarity and understanding of the Process / System.

The draft Protocols & Reports after completion of checking shall be destroyed; this shall be done in concerned Originating Department.

The Soft Copy of final Protocols & Reports shall be transferred to QA Department and the soft copy in other Departments shall be deleted in presence of QA person.

Master Copies of all Protocols & Reports shall be printed in QA department.

Protocols & Reports should be handled with care and should not be spoiled or torn. & No manual correction shall be made in Approved Copy.

All Master Copy / Soft Copy of Approved Protocols & Reports shall be stored in QA Department and Data Backup shall be kept in Information Technology (IT) Department.

All Protocols & Reports shall be prepared by Operating Officer / Executive of concerned Department, Reviewed by Head of the concerned Department / Head of related activity/Designe & Approved by Head Quality Assurance.

Note:

Irrespective of given Annexures of all protocol and reports, Headings and Sub headings shall be modified, new heading or sub heading shall be added and existing heading shall be deleted as per requirements.

Protocol / Report/Pre/post Approval

INITIATED BY

DESIGNATION	NAME	SIGNATURE	DATE
OFFICER / EXECUTIVE (DEPARTMENT)	–	–	–

REVIEWED BY

DESIGNATION	NAME	SIGNATURE	DATE
HEAD (DEPARTMENT)	–	–	–
HEAD (ENGINEERING)	–	–	–
MANAGER / DESIGNEE (QUALITY ASSURANCE)	–	–	–

APPROVED BY

DESIGNATION	NAME	SIGNATURE	DATE
HEAD (QUALITY ASSURANCE)	–	–	–

Protocols & Reports should have a unique Reference Number, which shall identify that document. The document number shall be given as per point No. 5.7 (Numbering system of protocol and report)

Content of Protocol/Report: content of protocol/report in the form of given table. Header Row of Table shall have gray 25 % Shading Colour.

PROTOCOL/REPORT CONTENTS:

S. No.	TITLE	PAGE NO.
–	–	–

Font size of table Content may be Changeable in case of insufficient space but it should be not less than 9 Font.

Depending upon System, Utility / Area the content of Protocol/Report may vary.

After preparation & approval of Protocol, Photocopy of Master Copy (as Controlled Copy) shall be used for Execution of Qualification / Validation activity.

After completion of Qualification / Validation, a Qualification / Validation Report shall compile. The Protocol / Report shall be reviewed by User Department i.e. QC Head / Engineering Head/ Production Head (as applicable), Approved by QA Head.

The approval of Qualification / Validation Report shall consider as handover of the system to user Department for its intended purpose.

Qualification Protocol shall be separate for DQ, IQ, OQ, & PQ for each activity & report also separate.

The activity flow for Qualification and Validation process is as:

The Responsibility & activity flow for Qualification and Validation process is as:

Content of Header and Footer:

Header:

The Header of Qualification/Validation documents shall have the Name of Organization (Including Name of Location). Header shall have the “Logo” of Organization in Left corner on Top and Title for Example “User Requirement Specification for———–” in centerwritten in Bold and Capital letter of font size 12 as shown in Annexure-VI.

Document no. Shall be written as per below next mentioned steps

Effective Date: Effective Date shall be assigned in the form of DD/MM/YY.Shall be written in bold and Capital Letter of Font Size 12. Shall be Pre-printed.

Page No.: Shall be written in Bold and Capital of Font Size 12. The Page Number shall be mentioned in ‘X of Y’ format. For Example: If a URS contains 60 pages, then the first page of the URS shall be 1 of 60 and the second page shall be 2 of 60 respectively. Shall be Pre-printed.

Footer:

Format No.: 09 Normal & Capital font size printed on the Left Corner of the page after Footer, out of page border and shall be printed as for Example: QA-003/F05-00 on all pages of the Protocol.

PREPARATION OF QUALIFICATION PROTOCOL AND REPORTS:

Note:

DQ, IQ, OQ and PQ are provided by vendor as per their format.

If not provided than in house DQ, IQ, OQ and PQ shall be prepared based on URS and information provided by vendor.

Preparation of Protocol shall be initiated after receipt of approved Specification and Design.

NUMBERING SYSTEM OF QUALIFICATION PROTOCOLS & REPORTS:

Each Protocols & Reports shall have unique No. for Identification and Control. Once a number is assigned to any Protocol & Report, the same number shall not be assigned to any other Protocols & Reports.

The Qualification Protocol and report (OQ, IQ, PQ) No. shall be assigned as:

For IQ the numbering system shall be assign as: WWW/XX/YYY/ZZZ

Where,

WWW – Indicate Qualification protocol/Report name e.g. (Installation Qualification Protocol/Report IQP/IQR)

XX- Indicate Machine Location e.g. (Production, QC/Micro)

YYY- Indicate Equipment Name e.g. (Tablet Compression Machine (TCM)) ZZZ – Indicate Equipment ID serial No. start from 001, 002, 003,004…………………

E.g., IQP/PD/TCM/001 and Report No. IQR/PD/TCM/001

For OQ the numbering system shall be assign as: WWW/XX/YYY/ZZZ

Where,

WWW – Indicate Qualification protocol/Report name e.g. (Operational Qualification Protocol/Report OQP/OQR)

XX- Indicate Machine Location e.g. (Production, QC/Micro)

YYY- Indicate Equipment Name e.g. (Tablet Compression Machine (TCM))

ZZZ – Indicate Equipment ID serial No. start from 001, 002, 003,004…………………

E.g. OQP/PD/TCM/001 and Report No. OQR/PD/TCM/001

For PQ the numbering system shall be assign as: WWW/XX/YYY/ZZZ

Where,

WWW – Indicate Qualification protocol/Report name e.g. (Performance Qualification Protocol/Report PQP/PQR)

XX- Indicate Machine Location e.g. (Production, QC/Micro)

YYY- Indicate Equipment Name e.g. (Tablet Compression Machine (TCM))

ZZZ – Indicate Equipment ID serial No. start from 001, 002, 003,004…………………

E.g. PQP/PD/TCM/001 and Report No. PQR/PD/TCM/001

AREA QUALIFICATION PROTOCOL AND REPORT

Area Qualification protocol and report shall be prepared by engineering person.

The numbering system for area qualification protocol and report as given below

XXX/YYY

Where,

XXX: Indicate Area Qualification protocol/Report

YYY: Indicate Serial No. start from 001, 002, 003……………….

E.g. AQP/001, AQR/001

USER REQUIREMENT SPECIFICATION (URS) –(As applicable):

The numbering system for user specification requirement shall be assigned as:

URS/XXX/YYY

URS: indicate user specification requirement

XXX: Equipment Name

YYY: Equipment ID No. start from 001, 002, 003……………

E.g. URS/AHU/001

Content of Header and Footer: refer point no. 5.2.24.

Content of Body Part:

URS shall contain following sections / Heads but not limited to:

Objective
Scope
Responsibility
Functional Requirements
GMP / GLP Requirements
Validation of Equipment/Instrument
Document Required
Safety Requirement
Constraints
Training Requirement
Discussion, Review and comments
Abbreviation
Approval Sheet
Revision History

The URS shall be numbered serially and the list of the same shall be maintained by Quality Assurance Department as per Annexure-IX &shall be updated Bi-annually or whenever required.

The URS shall be initiated by officer / Executive of user Department, Reviewed by Head of User Department/Designee i.e. QC / Engineering/ Production / Warehouse (which ever is applicable), Approved by QA Head/Designee.

A copy of approved URS shall be forwarded to vendor(s).

If there is any modification in the URS, the same shall be revised and the revised copy of the same shall be sent to the vendor(s).

On the basis of URS, the vendor(s) shall send the Design Specification (DS) and / or Functional Specification (FS).

The DS / FS received from the vendor(s), if found acceptable shall be approved by Head of User Department / QC / Engineering / Head Production and QA.

The Design of the system thus Qualified and Approved, is considered as Design Qualification (DQ). DQ shall be communicated to Vendor / Supplier.

Any change in the system after DQ shall be incorporated through Change Control.

Original and Approved URS along with DQ provided by the Vendor shall be submitted to Quality Assurance Department.

DESIGN QUALIFICATION :

Design Qualification shall be prepared based on DQ / URS documents and information provided by the vendor.

Design Qualification shall be prepared as per format shown in Annexure-I.

Content of Header and Footer: refer point no. 5.2.24.

Content of Body Part:

The format of Design Qualification shall contain the following sections but not limited to:

Equipment / Instrument / Utility Qualification:

Pre-Approval
Objective
Scope
Responsibility
Equipment / Instrument / System / Utility
Critical Variablesto be met:All critical variables with respect to Equipment / Instruments / System / Utility under qualification to be mentioned.
Equipment / Product Parameters
Utility Requirements / Location Suitability
Technical Specifications / Key Design Features
Safety
Vendor Selection
Documents to be attached:
Relevant Documents like Proposal, Purchase Order and Approved Diagram etc., to be attached.
Deviation from pre-defined specification, if any
Change control, if any
Review (inclusive of follow up action, if any)
Conclusion
Recommendation
Abbreviations
Revision history

Area Qualification:

Protocol Pre-Approval
Objective
Scope
Responsibility
Project Requirement
Design Qualification
Documents to be attached
Non compliance
Change Control, if any
Review (inclusive of follow up action, if any)
Recommendation
Conclusion
Abbreviations
Revision History

Water System:

Protocol Pre-Approval
Objective
Scope
Responsibility
Project Requirements
Brief Process Description
User Requirement Specification
Basis of System Design (For Purified Water Generation & Distribution System)
Basic Treatment Scheme and System Description
Basis of Design for Storage and Distribution of Purified Water
Critical Variables to be Met
Documents to be attached
Deviation From Pre-Defined Specification, if any
Change Control, if any
Review (inclusive of follow up action, if any)
Conclusion
Recommendation
Abbreviations
Revision History

INSTALLATION QUALIFICATION PROTOCOL (IQ):

Installation Qualification Protocol shall be prepared as per format shown in Annexure-II.

Content of Header and Footer: These are mentioned in subsequent paragraphs

Content of Body Part:

Format of Installation Qualification Protocol shall contain the following information but not limited to:

Equipment / Instrument / Utility Qualification:

Protocol approval

Objective

Scope

Responsibility

Equipment details

Installation qualification

Deviation from pre-defined specification if any

Change control, if any

Review (inclusive of follow up action, if any)

Conclusion

Recommendation Abbreviations Revision history

Area Qualification:

Protocol Pre-Approval
Objective
Scope
Responsibility
Project Requirement
Design Qualification
Documents to be attached
Non compliance
Change Control if any
Review (inclusive of follow up action, if any)
Recommendation
Conclusion
Abbreviations
Revision History

Water System:

Protocol Pre-Approval
Objective
Scope
Responsibility
Water System Details
Purified Water System Description
Critical Variables to be met
References
Documents to be attached
Deviation from Pre-defined Specification if any
Change Control, if any
Review (inclusive of follow up action, if any)
Conclusion
Recommendation
Abbreviations
Protocol Post Approval

Revision History

INSTALLATION QUALIFICATION REPORT (IQ):

Based on IQ protocol Qualification report shall be prepared as per format shown in Annexure-III.

Content of Header and Footer: These are mentioned in subsequent paragraphs

Content of Body Part:

Format of Installation Qualification Report shall contain the following information but not limited to:

Equipment / Instrument / Utility Qualification:

Report Pre-Approval
Objective
Scope
Responsibility
Equipment Details
Installation Qualification
Deviation from Pre-defined Specification if any
Change Control, if any
Review (inclusive of follow up action, if any)
Conclusion
Recommendation
Abbreviations
Report Post Approval
Revision History

Area Qualification:

Report Pre-Approval
Objective
Scope
Responsibility
Project Requirement
Design Qualification
Documentstobeattached
Non compliance
Change Control, if any
Review (inclusive of follow up action, if any)
Recommendation
Conclusion
Abbreviations
Report Post Approval
Revision History

Water System:

Report Pre-Approval
Objective
Scope
Responsibility
Water System Details
Purified Water System Description
Critical Variables to be met
References
Documents to be attached
Deviation from Pre-defined Specification if any
Change Control if any
Review (inclusive of follow up action, if any)
Conclusion
Recommendation
Abbreviations
Report Post Approval
Revision History

During and after installation of AHU duct the external area of the ductshall be check. So any gap between the ducts is not there and ensures external part should be affixed properly. Any extraneous part should not be exposed to outside the designated area of duct.

OPERATIONAL QUALIFICATION PROTOCOL:

Operational Qualification Protocol shall be prepared as per format shown in Annexure-IV.

Content of Header and Footer: are mention in above paragraphs.

Content of Body Part:

The format of Operational Qualification Protocol shall contain the following information but not limited to:

Equipment / Instrument / Utility Qualification:

Protocol Approval

Objective

Scope

Responsibility

Equipment details

Operational qualification

Deviation from Pre-Defined Specification if any

Change control if any

Review (inclusive of follow up action, if any)

Conclusion

Recommendation

Abbreviations

Revision History

Area Qualification:

Protocol Pre-Approval
Objective
Scope
Responsibility
Operational Qualification
Documents to be attached
Non compliance
Change Control, if any
Review (inclusive of follow up action, if any)
Recommendation
Conclusion
Abbreviations
Revision History

Water System:

Protocol Pre-Approval
Objective
Scope
Responsibility
Water System Details
Critical Variable to be met
References
Documents to be attached
Deviation from Pre-defined Specification, if any
Change Control, if any
Review (inclusive of follow up action, if any)
Conclusion
Recommendation
Abbreviations
Protocol Post Approval

OPERATIONAL QUALIFICATION REPORT:

Based on Operational Qualification Protocol Qualification report shall be prepared as per format shown in Annexure-V.

Content of Header and Footer: are mention in above paragraphs.

Content of Body Part: The format of Operational Qualification Report shall contain the following information but not limited to:

Equipment / Instrument / Utility Qualification:

Report Pre-Approval

Objective

Scope

Responsibility

Equipment details

Operational qualification

Deviation from Pre-defined Specification if any

Change control if any

Supporting attachments

Review (inclusive of follow up action, if any)

Conclusion

Recommendation

Abbreviations Report Post Approval

Revision History

Area Qualification:

Protocol Pre-Approval
Objective
Scope
Responsibility
Operational Qualification
Documents to be attached
Non compliance
Change Control, if any
Review (inclusive of follow up action, if any)
Recommendation
Conclusion
Abbreviations
Report Post Approval
Revision History

Water System:

Protocol Pre-Approval
Objective
Scope
Responsibility
Water System Details
Critical Variable to be met
References
Documents to be attached
Deviation from Pre-defined Specification, if any
Change Control, if any
Review (inclusive of follow up action, if any)
Conclusion
Recommendation
Abbreviations
Report Post Approval
Revision History

On completion of Installation Qualification of system, Operational Qualification shall be started.

On review of IQ & OQ documents provided by Vendor, if any deficiency is observed, same shall be discussed with vendor and such activity shall either be completed by vendor or undertaken by {Company Name} {Company Location}, and documented.

PERFORMANCE QUALIFICATION (PQ):

PERFORMANCE QUALIFICATION PROTOCOL:

Performance Qualification Protocol shall be prepared as per format shown in Annexure-VI.

Content of Header and Footer: are mention in above paragraphs.

Content of Body Part:

The format of Performance Qualification Protocol shall contain the following information but not limited to:

Equipment / Instrument / Utility Qualification:

Protocol approval

Objective

Scope

Responsibility

Equipment details

Performance qualification

Deviation from pre-defined specification if any

Change control if any

Review (inclusive of follow up action, if any)

Conclusion

Recommendation
Abbreviations
Revision history

Water System Qualification:

Protocol Approval
Objective
Scope
Responsibility
System Description
Flow Diagram of Generation of Water
Sampling Point Location and Specification for water validation Phase-I, II and III.
Measurements
Validation Procedure
Validation & Sampling
Validation Phase-I & II
Sampling Plan for Water System Validation Phase I & II
Validation Phase-III
Sampling Plan for Water System Validation Phase-III
Sampling Procedure & Testing
Method of Sampling
Sampling of Water for Chemical Analysis
Sampling of Water for Microbiological Analysis
Testing
Action & Alert Limits
Sanitization of Water System
Qualification of Water System
System Pre-requisites
Acceptance Criteria
Re-qualification Criteria and Change Control
Ongoing System Monitoring
References
Documents to be Attached
Non Compliance
Deviation from Pre-defined Specification if any
Change Control if any
Annexure
Abbreviations
Revision History

Area Qualification:

Protocol Approval
Objective
Scope
Responsibility
Project Requirement
Performance Qualification
Non Compliance
Deviation from Pre-defined Specification, if any
Change Control, if any
References
Documents to be attached
Abbreviations
Revision History

PERFORMANCE QUALIFICATION REPORT:

On the basis of Qualification Protocol, Qualification Report shall be prepared as per Annexure-VII.

Content of Header and Footer: are mention in above paragraphs.

Content of Body Part:

The format of Performance Qualification Report shall contain the following information but not limited to:

Equipment / Instrument / Utility Qualification Report:

Pre-Approval

Objective

Scope

Responsibility

Equipment details

Performance qualification

Deviation and corrective action

Change control, if any

Review (inclusive of follow up action, if any)

Conclusion

Recommendation

Abbreviation

Post approval signature

Revision history

Water System Qualification:

Report Pre-Approval
Objective
Scope
Responsibility
Validation Phase-I & II
Sampling Plan for Water System Validation Phase I & II
Validation Phase-III
Sampling Plan for Water System Validation Phase-III
Sampling Procedure & Testing
Method of Sampling
Sampling of Water for Chemical Analysis
Sampling of Water for Microbiological Analysis
Testing
Action & Alert Limits
Sanitization of Water System
Qualification of Water System
System Pre-requisites
Acceptance Criteria
Re-qualification Criteria and Change Control
Ongoing System Monitoring
References
Documents Attached
Non Compliance
Deviation from Pre-defined Specification, if any
Change Control, if any
Annexure
Review (inclusive of follow up action, if any)
Conclusion
Recommendation
Abbreviations
Report Post Approval
Revision History

Area Qualification:

Report Pre-Approval
Objective
Scope
Responsibility
Performance Qualification
Non Compliance
Deviation from Pre-defined Specification, if any
Change Control, if any
References
Documents attached
Review (inclusive of follow up action, if any)
Conclusion
Recommendation
Abbreviations
Report Post Approval

The Qualification Report shall be reviewed by Head of User Department, QC / Engineering / Production Head (as applicable) and approved by Head of QA. The approval of Qualification Report is considered as handover of the system to user Department for its intended purpose.

NUMBERING SYSTEM OF VALIDATION PROTOCOL AND REPORTS:

The Numbering system of validation protocol and reports shall be assigned as:

The validation Protocol No. shall be assigned as:

XXX/YYY

Where,

XXX: Indicate for name of protocol e.g. (Process validation protocol (PVP), Hold time study protocol (HTSP), Analytical method validation protocol (AMVP), Cleaning validation protocol (CVP) Stability study protocol (SSP)

YYY: Indicate serial No. start from 001, 002, 003, 004…………………

For Process Validation Protocol: E. g. PVP/001,

For Hold time study Protocol: E. g. HTSP/001

For analytical method validation Protocol: E.g. AMV/001

For cleaning validation Protocol: CVP/001 For stability study Protocol: SSP/001

The validation Report No. shall be assigned as:

XXX/YYY

Where,

XXX: Indicate for name of protocol e.g. (Process validation Report (PVR), Hold time study Report (HTSR), Analytical method validation Report (AMVR), cleaning validation Report (CVR) Stability study Report (SSP)

YYY: Indicate serial No. start from 001, 002, 003, 004…………………

For Process Validation Report: E. g. PVR/001

For Hold time study Report: E. g. HTSR/001

For analytical method validation Report: E.g. AMVR/001

For cleaning validation Report: CVR/001

For stability study Report: SSR/001

The numbering system for revalidation protocol and report

XXXX/YYY

XXXX: Indicate re-validation protocol name.

YYY: Indicate serial No. start from 001, 002, 003, 004……………….

E.g. RPVP/001

PREPARATION OF VALIDATION / RE-VALIDATION PROTOCOLS:

Process validation Protocols and reports shall be prepared as per relevant SOP. The format of process validation Protocol and report shall contain the following information.

PROCESS VALIDATION PROTOCOL:

Process Validation Protocol shall contain the following Heads but not limited to:

Protocol approval
Objective
Scope
Responsibility
Reason for validation
Process validation methodology
Training
Master document verification
Bill of material
Process validation pre-requisite
Product information
Specifications and standard test procedure
Equipment qualification verification
Environment condition of area
Process flow diagram
Process steps and critical process variables for validation
Methodology and sampling procedure for each stage
Critical quality attribute (CQA) and analysis plan
Process validation acceptance criteria
Revalidation
Deviation
Validation stability plan
Validation report
Conclusion
References
List of attachments
Abbreviations
Revision history

PROCESS VALIDATION REPORT:

Report pre- approval

Objective

Scope

Responsibility

Reason for validation

Training record

Document verification

Raw materials & packaging material dispensing verification:

Critical process variables

Temperature, relative humidity, pressure differential record during curing

Temperature, relative humidity, pressure differential record during inspection

Test result

Yield

Non conformance

Deviation from predefined specification

Change control, if any

Review (inclusive of follow up action

Conclusion

Recommendation

Abbreviation

Report post approval

Revision history

Hold Time Study Protocol (For Product):

Hold Time Study Protocol and report format shall be prepared as per relevant SOP. The hold time study protocol and repot shall contain the following contents:

Protocol approval

Introduction

· Objective

Scope

Responsibility

Training record

Detail of semi-finished (naked and pouched gummies) and selection criteria

Procedure

Sampling plan

Acceptance criteria for dispensed raw material

Acceptance criteria for semi-finished (naked gummies and pouched gummies)

Analytical method

Protocol certification

Approval of results

Revalidation criteria

References

Documents to be attached

Non conformance

Deviation from pre-defined specification if any

Change control if any

Review (inclusive of follow up action, if any)

Conclusion

Recommendation

Abbreviations

Revision history

Hold Time Study Report (For Product):

Report pre- approval

Introduction

Objective

Scope

Responsibility

Reason for qualification

Pre-qualification requirement

Qualification test result

Non conformance

Deviation from predefined specification

Change control if any

Review (inclusive of follow up action)

Conclusion

Recommendation

Abbreviation

Report post approval

Revision history

Analytical Method Validation Protocol:

Analytical Method Validation Protocol and report shall be prepared as per relevant SOP. The AMV Protocol and report shall contain the following contents:

Validation Team
Objective
Scope
Purpose
Responsibility
Training Details
Product Details
Selection for analytical performance parameter for AMV
Definition
Procedure for method validation
Validation Acceptance Criteria
References
Summary Report
Attachments
Deviation, if any
Conclusion
Recommendation
Abbreviations
Revision History

Analytical Method Report

Validation Team
Objective
Scope
Purpose
Responsibility
Training Details
Product Details
Selection for analytical performance parameter for AMV
Definition
Procedure for method validation
Validation Acceptance Criteria
References
Summary Report
Attachments
Deviation, if any
Conclusion
Recommendation
Abbreviations
Report Post Approval
Revision History

Stability Study Protocol:

The Stability study Protocol and report format shall be prepared as per relevant SOP. The stability study protocol and report shall contain following contents as given below:

Protocol approval

Objective

Scope

Responsibility

Training record of concerned personnel

Product information

Sample quantity for testing

Reason for stability study

Specification and test methodology information

Types of studies

Test results acceptance criteria Specification

Reference to analytical validation (stability indicating)

Sample charging and sample plan

Stability study report

Out of specification

Deviations / incidents

Change control

Equipment and storage malfunction

Commitment

Conclusion

Reference documents

Abbreviations

Revision History

Stability Study Report:

Stability Study Report shall contain the following heads but not limited to:

Report pre-approval

Objective

Scope

Responsibility

Training record of concerned personnel

Product information

Accelerated stability study test result

Long term stability study test result

Non conformance

Deviation from predefined specification

Change control, if any

Review (inclusive of follow up action)

Conclusion

Recommendation

Abbreviations

Report post approval

Revision History

Cleaning Validation Protocol:

Cleaning Validation Protocol and report format shall be prepared as per relevant SOP. The cleaning validation protocol and report shall contain the following contents as given below:

Protocol approval

Objective

Scope

Responsibility

Training details

Validation approach for campaign production, cleaning validation & hold time study

Criteria for selection of product for campaign production

Elements of cleaning process validation

Methodology of cleaning process validation

Acceptance criteria

Cleaned equipment hold time study

Environment monitoring

Testing method reference

Acceptance criteria

Re-validation criteria

References

Documents to be attached

Non conformance

Deviation from pre-defined specification, if any

Change control if any

Review (inclusive of follow up action, if any)

Conclusion

Recommendation

Abbreviations

Revision history

Cleaning Validation Report

Report pre-approval

Objective

Scope

Responsibility

Reason for validation

Pre-validation requirement

Documents verification

Cleaning validation study

Documents attached

Non conformance

Deviation from pre-defined specification, if any

Change control, if any

Review (inclusive of follow up action, if any)

Conclusion

Recommendation

Abbreviations

Report post approval

Revision history

System / Utility / other Validation Protocol:

System / Utility / Thermal Mapping / BET Validation and any Others Validation Protocol shall contain the following Heads but not limited to:

Protocol Approval
Objective
Scope
Responsibility
Reason for Validation
Site of Study
Training Details
Methodology
Master Document Verification
Acceptance Criteria
Validation / Re-Validation Criteria
Frequency of Validation
Change Control and Deviation
Conclusion
Recommendation
References
Documents to be Attached
Deviation From Pre-Defined Specification, If any
Change Control, If any
Abbreviations
Revision History

System / Utility / other Validation Report:

System / Utility / Thermal Mapping and any Others ValidationReport shall contain the following heads but not limited to:

Report Pre Approval
Objective
Scope
Responsibility
Reason for Validation
Site of Study
Training Details
Methodology
Master Document Verification
Acceptance Criteria
Validation / Re-Validation Criteria
Frequency of Validation
Change Control and Deviation
Conclusion
Recommendation
References
Documents to be attached.
Deviation From Pre-Defined Specification If any
Change Control If any
Abbreviations
Report Post Approval
Revision History

LAYOUT OF PROTOCOL CUM REPORTS, PROTOCOLS & REPORTS:

All Protocols & Reports shall contain Header, Footer and Body

The Line Spacing between two points or title & subtitle shall be 1.0 / 1.5 and font style shall be Times New Roman 12 font.

Paper Width 8.5”, Height 11.5” (Paper Size Custom) & Margin Top, Left, Right 24pt & Bottom Margin 31pt.

Protocols & Reports (Master Copy) shall be printed on A4 size Off-white colored Executive Bond Paper using “Times New Roman” Font with colour Ink.

Printing shall be done on one side of the paper only.

All Protocols & Reports contents shall be covered by Single Borderline (Line width ½ pt).

FONT SIZE OF HEADER, FOOTER & BODY CONTENTS:

NAME OF CONTENT	FONT SIZE
HEADER:
Name of the Organization	16 Bold & Capital
Location (Company Location)	12 Normal & Capital
Logo with {Company Name} (On Left Hand Side Corner of The Page)	Logo– Height-0.75’’& Width-0.66’’
Title of URS, Protocol & Report	12 Bold & Capital
URS / Protocol / Report No.	12 Bold & Capital
Effective Date	12 Bold & Capital
Page No. (In the form of X of Y)	12 Bold & Capital
FOOTER:
Format No.	09 Capital Normal
BODY:
Main Heading & Table Heading	12 Bold & Capital
Sub Heading	12 Normal & Bold
Table Contents Except Headings	12 Normal
FIRST PAGE CONTENT:
Title of Protocol & Report	28 Bold & Capital with Double Line Space
Table Content	12 Bold & Capital

STORAGE OF PROTOCOLS & REPORTS:

Master Qualification Protocols and Reports shall be stored in Quality Assurance Department.

If Protocol is revised, previous version of Protocol shall be made Obsolete and shall be archived for Historical purpose as per Document Retention Policy.

CONTROL, DISTRIBUTION & EXECUTION OF PROTOCOLS & REPORTS:

Controlled Copy of Protocols & Reports for Execution shall be distributed to respective Department by QA and details shall be recorded in format “Protocol / Report Issuance & Retrieval Record” as shown in Annexure-XIV.

QA shall put the ‘Controlled Copy Stamp” on each page of Protocols & Reports& distributed to different Departments for Execution Purpose.

A Master Index of Protocols & Reports shall be maintained by QA Department in format “Master Validation / Qualification Report Index” as shown in Annexure-XII, XIII.

The Index of Protocols and Reports shall be updated at the frequency of two Year or whenever required, manual corrections shall not be allowed in this Index.

In case of discontinuation of the Protocol and Report, the Protocol and Report may be discontinued; however the same Protocol and Report No. shall not be allotted to any newly prepared Protocol and Report.

All Master Copy of Protocols and Reports shall be stamped as “MASTER COPY” in red ink on all the pages. Specimen of Master Copy stamp is shown in SOP No.: QA/001.

The Execution Copy of Protocol shall be distributed by making Photostat copies of the Master Copy and shall be stamped as “CONTROLLED COPY” in green ink at the Right Upper Corner on all pages of Protocol. Specimen of Controlled Copy stamp is shown in SOP No.: QA/001.

In case, if any Protocol and Report is submitted to the External Agencies (i.e. Regulatory, Customers etc.) a photocopy of Master Copy / Executed Copy shall be made by QA and shall be stamped as “UNCONTROLLED COPY” in Violet ink on Left Corner of the page below footer.

The Copy of Protocol and Report that is meant only for Information / Reference purpose shall be made by Photostat of Master Copy / Executed Copy (in case of executed Protocol / Report).

If Soft Copy of Protocol and Report is forwarded, it shall be submitted as “Read only” protected PDF format.

Protocols & Reports shall be revised only if any change is required, if there is no change continue with same protocol & report.

Revision of Protocol and Report shall be regulated through “Change Control Procedure”. The Obsolete Copy shall be stamped as “OBSOLETE COPY” in Black Ink in the Left Upper Corner of all the pages. Specimen of Obsolete Copy Stamp is shown in SOP No.: QA/001.

The Master Copy of Protocol and Report which is discontinued, or which is cancelled due to implementation of any new Protocol and Report shall be stamped as “CANCELLED COPY” in Black Ink at the Left Upper Corner of all the pages.

Index of Qualification Documents shall be prepared as per Format shown in Annexure-, X, XI, XII, and XIII.

DESTRUCTION OF PROTOCOLS & REPORTS:

All Qualification & Validation Documents (i.e. Process Validation Protocols / Reports, Stability Data & Documents, Qualification & Validation Documents for Critical Utilities / System / Equipments etc.) shall be retained till the life of the Organization.

REFERENCES:

A WHO guide to Good Manufacturing Practice (GMP) requirements (Part 2: Validation).

QA SOP No. QA/001, “Preparation, Approval, Control, Distribution, Revision, Retrieval & Destruction of Standard Operating Procedure”.

ANNEXURES:

ANNEXURE No.	TITLE OF ANNEXURE	FORMAT No.
Annexure-I	Protocol For Design Qualification	QA-003/F01-00
Annexure-II	Protocol For Installation Qualification	QA-003/F02-00
Annexure-III	Report For Installation Qualification	QA-003/F03-00
Annexure-IV	Protocol For Operational Qualification	QA-003/F04-00
Annexure-V	Report For Operational Qualification	QA-003/F05-00
Annexure-VI	Performance Qualification Protocol	QA-003/F06-00
Annexure-VII	Performance Qualification Report	QA-003/F07-00
Annexure-VIII	User Requirement Specification	QA-003/F08-00
Annexure- IX	User Requirement Specification Index	QA-003/F09-00
Annexure-X	Master Equipment / Area / Utility Qualification Documents Index	QA-003/F10-00
Annexure-XI	Master Validation / Qualification Protocol Index	QA-003/F11-00
Annexure-XII	Master Validation / Qualification Report Index	QA-003/F12-00
Annexure-XIII	Protocol / Report Issuance & Retrieval Record	QA-003/F13-00

ENCLOSURES: SOP Training Record.

DISTRIBUTION:

Controlled Copy No. 01 : Head Quality Assurance
Controlled Copy No. 02 : Head Quality Control
Controlled Copy No. 03 : Head Production
Controlled Copy No. 04 : Head Engineering
Controlled Copy No. 05 : Head Warehouse
Master Copy : Quality Assurance Department

ABBREVIATIONS :

Ltd.	:	Limited
SOP	:	Standard Operating Procedure
No.	:	Number
QA	:	Quality Assurance
QC	:	Quality Control
S. No.	:	Serial Number
HPLC	:	High Performance Liquid Chromatography
FS	:	Functional Specification
DS	:	Design Specification
VMP	:	Validation Master Plan
IT	:	Information Technology
API	:	Active Pharmaceutical Ingredients
SS	:	Stainless Steel
AHU	:	Air Handling Unit
GPT	:	Growth Promotion Test
PDF	:	Portable Document Format
ID No.	:	Identification Number
URS	:	User Requirement Specification
DQ	:	Design Qualification
IQ	:	Installation Qualification
OQ	:	Operational Qualification
PQ	:	Performance Qualification