contamination, and potential cross-contaminants, in accordance with cGMP, ICH Q7, and WHO Annex 6 guidelines.

2. Scope

This SOP applies to all cleaning validations performed on equipment used in sterile injectable manufacturing such as filling machines, solution tanks, lyophilizers, and associated processing components at [Company Name]’s manufacturing site.

3. Responsibilities

• Quality Assurance: Approves protocols, oversees execution, reviews validation reports, and ensures regulatory compliance.
• Production: Executes cleaning and assists in swab/rinse sampling.
• QC (Quality Control): Analyzes swab and rinse samples for residues, bioburden, and cleaning agent levels.
• Validation Team: Prepares and executes cleaning validation protocol and final report.

4. Accountability

The Validation Manager is accountable for successful planning, execution, and documentation of cleaning validation activities in compliance with regulatory expectations.

5. Procedure

5.1 Selection of Equipment and Products

1. Identify worst-case product(s) based on solubility, toxicity, difficulty to clean, and batch size.
2. Prioritize equipment that is shared across products or production lines.

5.2 Cleaning Validation Protocol

1. Prepare a protocol that includes:
   • Objective and scope
   • Roles and responsibilities
   • Sampling procedures
   • Acceptance criteria
   • Analytical methods
   • Number of validation runs (minimum 3 consecutive)
2. QA shall review and approve the protocol before initiation.

5.3 Sampling Methods

• Swab Sampling: Use sterile swabs moistened with extraction solution; swab defined surface area (25 cm² or as per protocol).
• Rinse Sampling: Use WFI or purified water to rinse equipment; collect and analyze rinse sample.

5.4 Sample Analysis

1. Swab samples analyzed for product residue using validated HPLC/UV methods.
2. Rinse samples analyzed for detergent residue, microbial contamination, and bioburden.
3. Limit of Detection (LOD) and Limit of Quantitation (LOQ) of analytical methods must be validated.

5.5 Acceptance Criteria

• No detectable residue above acceptable limit (e.g., NMT 10 ppm or 1/1000 of lowest therapeutic dose).
• No microbial growth above alert/action limits.
• Detergent levels must comply with product safety limits.

5.6 Revalidation

1. Revalidation shall be conducted when:
   • New equipment is introduced
   • Change in cleaning procedure or detergent
   • Product or batch size change

5.7 Documentation

1. All results shall be documented in the Cleaning Validation Report (Annexure-3).
2. QA to retain final report and raw data as part of GMP documentation.

6. Abbreviations

• SOP: Standard Operating Procedure
• LOD: Limit of Detection
• LOQ: Limit of Quantitation
• QC: Quality Control
• WFI: Water for Injection

7. Documents

1. Cleaning Validation Protocol – Annexure-1
2. Swab and Rinse Sample Log – Annexure-2
3. Cleaning Validation Report – Annexure-3

8. References

• ICH Q7: Good Manufacturing Practice for Active Pharmaceutical Ingredients
• WHO TRS 961 Annex 6: GMP for Sterile Pharmaceutical Products
• 21 CFR Part 211: cGMP for Finished Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Cleaning Validation Protocol

Protocol ID	Equipment	Product	Validated By
CVP-2025-01	Vial Filler	Injection A	Sunita Reddy

Annexure-2: Swab and Rinse Sample Log

Date	Sample Type	Equipment	Collected By	Analyzed By
15/06/2025	Swab	Tank-1	Rajesh Kumar	Anita Mehra
15/06/2025	Rinse	Tank-1	Rajesh Kumar	Anita Mehra

Annexure-3: Cleaning Validation Report

Report ID	Date	Equipment	Conclusion	Approved By
CVR-2025-01	17/06/2025	Tank-1	Pass	QA Head

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial version	New SOP	QA Head
18/06/2025	2.0	Updated protocol and sampling annexures	Annual Review	QA Head