cleaning validation including gel mixers, holding tanks, transfer pipes, and homogenizers.

3. Responsibilities

• Quality Assurance: Approve validation protocols and review reports.
• Validation Team: Conduct the validation studies, collect data, and analyze results.
• Production: Perform cleaning as per SOPs and support swab sampling.
• Microbiology/Analytical Lab: Perform analysis of swab and rinse samples.

4. Accountability

The Head of QA and Head of Manufacturing are accountable for the compliance and execution of this SOP.

5. Procedure

5.1 Preparation of Cleaning Validation Protocol

1. Define objective, scope, responsibilities, and acceptance criteria in the protocol.
2. List equipment to be validated and the worst-case product based on solubility, potency, and cleaning difficulty.
3. Define sampling locations, frequency, and analytical methods.

5.2 Cleaning Execution

1. Execute cleaning as per the standard cleaning SOP specific to the equipment.
2. Ensure usage of validated cleaning agents and tools.

5.3 Sampling Method

1. Use both swab sampling and rinse sampling depending on equipment accessibility.
2. Swab defined areas (typically 25 cm²) using pre-moistened sterile swabs.
3. Rinse with measured volume of suitable solvent and collect final rinse samples.

5.4 Analytical Testing

1. Test samples for:
   • Residual active pharmaceutical ingredient (API)
   • Cleaning agent residues
   • Microbial contaminants
2. Use validated analytical methods such as TOC, HPLC, or UV spectrophotometry.

5.5 Acceptance Criteria

• Residue levels must be below the Maximum Allowable Carry Over (MACO).
• Cleaning agent residues must not exceed internally set limits.
• Microbial count must be <10 CFU/swab.

5.6 Documentation

1. Record all data in the Cleaning Validation Report (CVR).
2. Include swab results, rinse results, equipment ID, batch numbers, and cleaning date.

5.7 Report Approval and Finalization

1. QA to review and approve the validation summary report.
2. If results are within limits, the equipment is considered qualified for routine manufacturing.

6. Abbreviations

• CVR: Cleaning Validation Report
• CFU: Colony Forming Units
• MACO: Maximum Allowable Carry Over
• QA: Quality Assurance
• HPLC: High Performance Liquid Chromatography
• TOC: Total Organic Carbon

7. Documents

1. Cleaning Validation Protocol – Annexure-1
2. Swab and Rinse Sampling Data Sheet – Annexure-2
3. Cleaning Validation Report Format – Annexure-3

8. References

• ICH Q7: GMP for Active Pharmaceutical Ingredients
• WHO TRS 986: Annex 2
• FDA Guidance on Cleaning Validation

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Cleaning Validation Protocol

Equipment Name	Product	Worst Case Selection	Sampling Points	Acceptance Criteria

Annexure-2: Swab and Rinse Sampling Data Sheet

Date	Equipment ID	Sample Type	Location	Result	Limit	Pass/Fail
		Swab
		Rinse

Annexure-3: Cleaning Validation Report Format

Validation ID	Equipment Name	Product	Date of Cleaning	Analytical Method	Result Summary	QA Review

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
05/06/2022	1.0	Initial Release	New SOP	QA Head
02/06/2025	2.0	Expanded to include microbial limits and updated formats	Regulatory Update	QA Head