Procedure for Validation of Cleaning Processes

Department	Quality Assurance (QA)/Production/Quality Control (QC)
SOP No.	SOP/Ointment/114
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 a systematic approach for the validation of cleaning processes 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), Production, and Quality Control (QC) departments involved in the validation of cleaning procedures for equipment and manufacturing areas used in ointment production.

3. Responsibilities

• Production Supervisor: Ensures the execution of cleaning procedures as per the validation protocol.
• QA Officer: Ensures compliance with GMP and regulatory requirements for cleaning validation.
• QC Analyst: Conducts residue analysis to verify cleaning effectiveness.
• Validation Team: Performs cleaning validation trials and compiles data.
• QA Manager: Approves the cleaning validation protocol and final validation report.

4. Accountability

The QA and Production Managers are accountable for ensuring that cleaning validation is conducted as per ICH, WHO, and FDA guidelines.

5. Procedure

5.1 Validation Planning

• Develop a Cleaning Validation Protocol that includes:
  • Objective and scope of validation
  • List of equipment and surfaces to be cleaned
  • Cleaning agents, methods, and parameters
  • Acceptance criteria for residue levels
• Identify sampling points for swab and rinse water testing.
• Ensure equipment is in a clean and idle state before validation.

5.2 Execution of Cleaning Validation Batches

• Conduct a minimum of three consecutive validation batches to confirm cleaning consistency.
• Ensure that each cleaning cycle follows the same parameters, including:
  • Type and concentration of cleaning agents
  • Cleaning duration and temperature
  • Rinse cycles and drying methods
• Perform in-process verification of cleaning efficiency.

5.3 Testing and Evaluation of Validation Data

• Conduct residue testing for active pharmaceutical ingredients (APIs), excipients, and cleaning agents.
• Perform microbiological analysis to confirm removal of contaminants.
• Compare results with predefined acceptance criteria.

5.4 Process Optimization

• If residue levels exceed limits, refine the cleaning process.
• Adjust cleaning parameters and conduct additional validation trials if necessary.
• Document all changes and optimizations in the Validation Report.

5.5 Approval and Finalization

• QA must review and approve the Cleaning Validation Report.
• Ensure validated cleaning procedures are incorporated into Standard Cleaning Procedures (SCPs).
• Maintain validation records for regulatory audits and inspections.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• ICH – International Council for Harmonisation
• SCP – Standard Cleaning Procedure

7. Documents

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

8. References

• ICH Q7 – Good Manufacturing Practice Guide
• WHO GMP 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

Validation Parameter	Specification	Acceptance Criteria
Cleaning Agent	Sodium Lauryl Sulfate	0.001% Residue Limit
Rinse Water Conductivity	<10 µS/cm	Pass
Microbial Contamination	<100 CFU/mL	Compliant

Annexure-2: Cleaning Validation Report

Batch Number	Residue Level	Microbial Count	Final Approval
OINT-1401	Compliant	Within Limits	QA Manager
OINT-1402	Compliant	Within Limits	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