CFR Part 11.

2. Scope

This SOP applies to all departments involved in preparing, reviewing, and approving cleaning validation reports at sterile injectable manufacturing facilities, including Production, QA, QC, and Engineering.

3. Responsibilities

• Validation Executive: Drafts the cleaning validation report based on raw data and test results.
• QA Officer: Reviews documentation for compliance, completeness, and traceability.
• QC Analyst: Provides analytical results and test data for inclusion.
• Engineering: Supports in providing equipment diagrams and specifications.

4. Accountability

The Head of Quality Assurance is accountable for ensuring the accuracy, approval, and archival of cleaning validation reports.

5. Procedure

5.1 Collection of Data

1. Obtain raw data from the executed cleaning validation protocol including:
   • Swab/rinse test results
   • Analytical test data
   • Microbial counts (if applicable)
   • Environmental monitoring data
   • Visual inspection results

5.2 Structure of the Report

The cleaning validation report shall include the following sections:

1. Title Page: Equipment ID, Product Name, Date, Report No., Version No.
2. Objective: Summary of what was validated and why.
3. Scope: Equipment and systems covered in the validation.
4. Protocol Reference: Document No. of executed protocol.
5. Methodology: Sample collection, acceptance criteria, testing methods.
6. Results Summary: Tabulated test results and observations.
7. Deviations (if any): Description, root cause, and corrective actions.
8. Conclusion: Summary of results versus acceptance criteria.
9. Annexures: Supporting documents and raw data (Annexure-1, 2, 3…)

5.3 Report Numbering

1. Use the format: CVR/[Equipment ID]/[Year]/[Serial No.]
2. E.g., CVR/FL02/2025/003

5.4 Review and Approval

1. Report is first reviewed by Validation and QA teams.
2. QC test results should be cross-checked for limits, detection method, and analyst sign-off.
3. Once reviewed, forward to Head QA and Head Production for final approval.

5.5 Archival and Retrieval

1. Submit signed and approved report to QA for archival.
2. Store reports in a controlled-access document storage room with index file.
3. Maintain soft copies in validated Document Management System (DMS).

5.6 Deviations and OOS

1. Document any deviations using Annexure-4: Deviation Form.
2. Out-of-specification (OOS) results must be investigated per SOP for OOS handling.

5.7 Change Control

1. If changes in equipment, product, or cleaning method occur, initiate change control.
2. Revalidation must be performed as per change control approval.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• DMS: Document Management System
• CVR: Cleaning Validation Report
• OOS: Out of Specification

7. Documents

1. Annexure-1: Sample Cleaning Validation Report Template
2. Annexure-2: Cleaning Data Summary Table
3. Annexure-3: Approval Record Sheet
4. Annexure-4: Deviation Form

8. References

• ICH Q7: GMP for Active Pharmaceutical Ingredients
• 21 CFR Part 211
• EU Guidelines to GMP, Annex 15

9. SOP Version

Version: 2.0

10. Approval Section

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

11. Annexures

Annexure-1: Cleaning Validation Report Template

Report Title	Cleaning Validation Report for FL02
Equipment ID	FL02
Date of Validation	20/06/2025
Executed By	Ramesh Iyer
Approved By	Sunita Reddy

Annexure-2: Cleaning Data Summary Table

Sample Location	Result (μg/swab)	Acceptance Limit	Status
Filling Needle	1.8	≤2.0	Pass
Tank Outlet	2.2	≤2.5	Pass

Annexure-3: Approval Record Sheet

Reviewer	Signature	Date
QA
Head QA

Annexure-4: Deviation Form

Deviation No.	Date	Description	Corrective Action
DEV/2025/06	20/06/2025	Missed Swab Site	Repeat Swab, retrain staff

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	Head QA
24/06/2025	2.0	Updated format and structure of report documentation	Annual Review	Head QA