reports submitted by the Validation, Engineering, Production, and QC departments within the API manufacturing facility. It covers prospective, concurrent, and retrospective validation activities.

3. Responsibilities

• Validation Team: Prepares validation protocols and final reports based on validation plans.
• Concerned Departments: Provide required operational, process, or analytical data.
• QA Department: Reviews content, compliance, and completeness of protocols and reports and approves or requests revision.

4. Accountability

The Head of Quality Assurance is accountable for the final review and approval of all validation-related documents, ensuring compliance with regulatory expectations and internal policies.

5. Procedure

5.1 Receipt of Validation Protocol

1. The Validation team shall submit the draft protocol to QA with a completed Protocol Submission Form (Annexure-1).
2. QA shall log the receipt in the Validation Protocol Tracking Register (Annexure-2).

5.2 Review of Validation Protocol

1. QA shall review the validation protocol for the following key elements:
   • Title, version, and objective
   • Scope and justification for validation
   • Responsibilities of involved departments
   • List of equipment, materials, or methods to be validated
   • Acceptance criteria
   • Risk assessment, where applicable
   • Test procedure, frequency, and sampling plan
   • Approval signatures of all relevant stakeholders
2. QA shall record observations, if any, using the Protocol Review Comment Form (Annexure-3).
3. Once approved, QA shall sign the final version and retain a controlled copy.

5.3 Execution and Submission of Validation Report

1. After execution, the validation team shall compile and submit a final validation report with all supporting raw data.
2. The report must include:
   • Summary of execution
   • Deviations, if any, and their impact assessment
   • Results and acceptance status
   • Conclusion and recommendation
   • Final approval signatures

5.4 Review of Validation Report by QA

1. QA shall verify:
   • All protocol activities executed as per plan
   • Results meet pre-defined acceptance criteria
   • All deviations and changes are documented with CAPA (if needed)
   • Raw data is complete, legible, and traceable
2. Use the Validation Report Review Checklist (Annexure-4) during review.
3. For rejected or incomplete reports, QA shall request resubmission.

5.5 Approval and Archival

1. Upon satisfactory review, QA shall sign the final report and update the Validation Report Register (Annexure-5).
2. Controlled copies of approved documents shall be archived in the QA Document Control Room with appropriate indexing.

6. Abbreviations

• QA: Quality Assurance
• QC: Quality Control
• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action
• IQ/OQ/PQ: Installation/Operational/Performance Qualification

7. Documents

1. Protocol Submission Form (Annexure-1)
2. Validation Protocol Tracking Register (Annexure-2)
3. Protocol Review Comment Form (Annexure-3)
4. Validation Report Review Checklist (Annexure-4)
5. Validation Report Register (Annexure-5)

8. References

• ICH Q7 – Section 12: Validation
• EU GMP Annex 15 – Qualification and Validation
• 21 CFR Part 211.100, 211.160 – Process and Laboratory Controls
• WHO Technical Report Series 1019 – Annex 3

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Protocol Submission Form

Protocol No.	Type	Submitted By	Date
VAL/PROC/2025/001	Cleaning Validation	Rajesh Kumar	10/04/2025

Annexure-2: Validation Protocol Tracking Register

Protocol No.	Title	Submission Date	Status
VAL/PROC/2025/001	Cleaning of API Reactor R-01	10/04/2025	Approved

Annexure-3: Protocol Review Comment Form

Protocol No.	Observation	Suggested Action	QA Reviewer
VAL/PROC/2025/001	Missing acceptance criteria	Include clear pass/fail criteria	Sunita Reddy

Annexure-4: Validation Report Review Checklist

Checklist Point	Status	Remarks
All protocol steps executed	Yes	Compliant
Deviations addressed	Yes	CAPA implemented
Results meet acceptance criteria	Yes	Satisfactory

Annexure-5: Validation Report Register

Report No.	Protocol Ref	Approval Date	Archived By
VAL/PROC/2025/RPT-001	VAL/PROC/2025/001	14/04/2025	QA Archive Team

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial release	New SOP	QA Head
14/04/2025	2.0	Integrated tracking system and archival steps	Compliance Update	QA Head