Procedure for Establishing Cleaning Validation Protocols

Department	Quality Assurance (QA)/Validation/Production
SOP No.	SOP/Ointment/121
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 process for establishing cleaning validation protocols in ointment manufacturing. This ensures that cleaning procedures effectively remove residues, prevent cross-contamination, and comply with regulatory requirements.

2. Scope

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

3. Responsibilities

• QA Officer: Ensures cleaning validation protocols meet regulatory standards.
• Validation Team: Develops and executes cleaning validation studies.
• Production Supervisor: Ensures adherence to validated cleaning procedures.
• QC Analyst: Conducts residue analysis to verify cleaning effectiveness.
• QA Manager: Approves cleaning validation protocols and reports.

4. Accountability

The QA and Validation Managers are accountable for ensuring that cleaning validation protocols comply with GMP, FDA, ICH, and WHO guidelines.

5. Procedure

5.1 Development of Cleaning Validation Protocols

• Identify equipment and surfaces requiring validation.
• Define acceptance criteria for cleaning effectiveness.
• Establish sampling methods (swab, rinse, visual inspection).
• Determine analytical methods for residue detection.
• Specify the number of cleaning validation runs required.

5.2 Approval of Cleaning Validation Protocols

• QA must review and approve cleaning validation protocols.
• Ensure all parameters comply with regulatory requirements.
• Document the protocol approval in the validation master file.

5.3 Execution of Cleaning Validation

• Conduct cleaning validation trials using approved methods.
• Record all observations and deviations in real-time.
• Collect and analyze cleaning residue samples.

5.4 Assessment and Review

• Compare test results with predefined acceptance criteria.
• Identify trends and areas for process optimization.
• Implement corrective actions for any deviations observed.

5.5 Final Validation Report

• Summarize cleaning validation results and compliance status.
• Obtain final approval from the QA Manager.
• Maintain cleaning validation records for regulatory audits.

6. Abbreviations

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

7. Documents

• Cleaning Validation Protocol Template (Annexure-1)
• Cleaning Validation Report (Annexure-2)

8. References

• ICH Q7 – Good Manufacturing Practice Guide
• WHO Guidelines for Cleaning Validation
• US FDA Guidance on Cleaning 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: Cleaning Validation Protocol Template

Section	Description
Objective	Defines the purpose of cleaning validation
Scope	Details equipment and areas covered
Acceptance Criteria	Defines residue limits
Sampling Methods	Swab, rinse, and visual inspection

Annexure-2: Cleaning Validation Report

Equipment ID	Test Parameter	Result	Final Approval
MIX-2001	Residue Level	Compliant	QA Manager
FILL-3002	Microbial Load	Pass	QA Manager

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