surfaces used in the production of Active Pharmaceutical Ingredients (APIs). It covers cleaning validation protocol review, sample plan approval, result assessment, and final validation report authorization.

3. Responsibilities

• QA Executive: Coordinates validation activities, witnesses sampling, and verifies documentation.
• QA Manager: Reviews and approves validation protocols, final reports, and deviation justifications.
• QA Analyst: Ensures adherence to sample plan and maintains records of test results.

4. Accountability

The Head of Quality Assurance is accountable for ensuring all cleaning validation activities are compliant with cGMP, properly documented, and aligned with applicable guidelines.

5. Procedure

5.1 Cleaning Validation Plan Review

1. QA shall review the Annual Cleaning Validation Master Plan (CVMP) (Annexure-1) to ensure it includes:
   • List of equipment and products covered
   • Selection criteria for worst-case product
   • Sampling locations and limits
   • Acceptance criteria and revalidation frequency

5.2 Protocol Review and Approval

1. QA shall ensure cleaning validation protocols include:
   • Objective and scope
   • Sampling and test method details
   • Acceptance limits (e.g., MACO calculations)
   • Recovery factor validations
2. All protocols must be reviewed for accuracy, feasibility, and regulatory compliance before final QA approval (Annexure-2).

5.3 Pre-Validation Activities

1. QA shall:
   • Ensure cleaning procedures and materials (detergents, rinse media) are validated
   • Check equipment status (line clearance, batch records)
   • Verify availability of qualified personnel for sample collection

5.4 Sample Plan Approval and Witnessing

1. QA shall review and sign the Cleaning Validation Sample Plan (Annexure-3), confirming:
   • Swab and rinse sampling locations
   • Number of samples per equipment surface
   • Sample container labeling and documentation
2. QA must witness sample collection or review the sample transfer logs immediately post-collection.

5.5 Test Result Review and Trend Analysis

1. QA shall evaluate test results for:
   • Residue levels (µg/swab or ppm)
   • Microbial contamination
   • Cleaning agent residuals (where applicable)
2. Results shall be trended using the Cleaning Validation Results Log (Annexure-4) to detect any deviations or inconsistencies.

5.6 Deviations and Investigation

1. If acceptance criteria are not met:
   • QA shall initiate a deviation report
   • Conduct root cause analysis
   • Approve additional cleaning and re-sampling
2. All deviations must be addressed before final report approval.

5.7 Approval of Final Cleaning Validation Report

1. QA Manager shall review:
   • Protocol adherence
   • Test results and acceptance
   • Deviations and CAPAs (if any)
2. QA shall approve the Cleaning Validation Summary Report (Annexure-5) and archive all related records.

5.8 Revalidation Criteria

1. QA shall initiate revalidation in cases of:
   • Product change or new product introduction
   • Equipment modification or relocation
   • Change in cleaning procedure or material

6. Abbreviations

• QA: Quality Assurance
• CVMP: Cleaning Validation Master Plan
• SOP: Standard Operating Procedure
• MACO: Maximum Allowable Carryover
• cGMP: current Good Manufacturing Practice

7. Documents

1. Cleaning Validation Master Plan (CVMP) – Annexure-1
2. Cleaning Validation Protocol Review Form – Annexure-2
3. Cleaning Validation Sample Plan – Annexure-3
4. Cleaning Validation Results Log – Annexure-4
5. Cleaning Validation Summary Report – Annexure-5

8. References

• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• FDA Guidance for Industry: Cleaning Validation (2001)
• EU GMP Annex 15 – Qualification and Validation
• WHO TRS 937 Annex 4 – GMP Guidelines for APIs

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 Master Plan

Equipment	Worst-Case Product	Sampling Points	Validation Frequency
Reactor R-101	Product X	3 Swab Points	Annual

Annexure-2: Cleaning Validation Protocol Review Form

Protocol No.	Reviewed By	Date	Comments
CVP-025	QA Manager	10/04/2025	Compliant

Annexure-3: Cleaning Validation Sample Plan

Equipment	Location	Sample Type	Sample ID
Dryer D-02	Outlet Valve	Swab	CVS-1001

Annexure-4: Cleaning Validation Results Log

Sample ID	Residue Level	Limit	Status	Analyst
CVS-1001	2.3 µg	≤ 10 µg	Pass	Sunita Reddy

Annexure-5: Cleaning Validation Summary Report

Report No.	Equipment	Validated On	Approved By	Status
CVSR-025	Dryer D-02	12/04/2025	QA Head	Approved

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Issue	New SOP	QA Head
14/04/2025	2.0	Updated roles and annexure format	Audit Observation	QA Head