SOP for Validation Protocol Approval – V 2.0

Procedure for Validation Protocol Approval

Department	Quality Assurance (QA)/Validation/Production
SOP No.	SOP/Ointment/118
Supersedes	V 1.0
Page No.	Page X of Y
Issue Date	[Insert Issue Date]
Effective Date	[Insert Effective Date]
Review Date	[Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the approval process for validation protocols in ointment manufacturing. This ensures that all validation activities are planned, reviewed, and authorized before execution.

2. Scope

This SOP applies to all personnel in the Quality Assurance (QA), Validation, and Production departments responsible for reviewing, approving, and managing validation protocols.

3. Responsibilities

Validation Officer: Prepares validation protocols and ensures they align with regulatory guidelines.
QA Officer: Reviews the protocol for completeness and compliance.
Production Supervisor: Confirms protocol feasibility and operational applicability.
QA Manager: Approves the protocol before execution.
Regulatory Affairs (if applicable): Ensures the protocol meets regulatory requirements.

4. Accountability

The QA and Validation Managers are accountable for ensuring that validation protocols are reviewed, approved, and documented as per GMP, FDA, ICH, and WHO guidelines.

5. Procedure

5.1 Validation Protocol Preparation

The Validation Officer drafts the validation protocol, including:
- Purpose and scope of validation
- Equipment, materials, and methods used
- Critical parameters and acceptance criteria
- Testing methodology and sampling plan
- Approval section for signatures
The draft protocol is circulated to QA and Production for initial review.

5.2 Review and Revisions

QA reviews the protocol to

ensure compliance with regulatory requirements.

Production confirms the feasibility of executing the protocol under routine conditions.

Any necessary revisions are incorporated, and the document is updated.

5.3 Approval Process

Once finalized, the validation protocol is submitted for approval.
Signatures are obtained from:
- Validation Officer
- Production Supervisor
- QA Manager
- Regulatory Affairs (if applicable)
QA retains a master copy of the approved protocol.

5.4 Execution and Monitoring

The approved protocol is executed as per the defined procedures.
QA monitors the validation study to ensure adherence to the protocol.
Any deviations are recorded and assessed.

5.5 Validation Report Preparation

Upon completion of the validation study, a final report is prepared.
The report includes:
- Summary of test results
- Deviation records (if any)
- Conclusion and recommendations
The final validation report undergoes the same approval process as the protocol.

6. Abbreviations

GMP – Good Manufacturing Practices
QA – Quality Assurance
FDA – Food and Drug Administration
ICH – International Council for Harmonisation

7. Documents

Validation Protocol Template (Annexure-1)
Validation Approval Log (Annexure-2)

8. References

ICH Q7 – Good Manufacturing Practice Guide
WHO Guidelines for Validation of Manufacturing Processes
US FDA Guidance on Process Validation

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Validation Protocol Template

Section	Description
Objective	Defines the purpose of validation
Scope	Details the areas covered
Acceptance Criteria	Defines critical parameters
Testing Methodology	Describes tests performed

Annexure-2: Validation Approval Log

Validation Protocol ID	Approval Date	Approved By	Comments
VAL-2025-001	01/02/2025	QA Manager	Approved without changes
VAL-2025-002	05/02/2025	QA Manager	Minor revisions incorporated

12. Revision History:

Revision Date	Revision No.	Details of Revision	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Updated SOP Format	Standardization of Document	QA Head