Ensures that the cleaning validation documentation complies with applicable regulatory standards.

4. Accountability

The Manufacturing Manager is accountable for ensuring that cleaning validation activities are properly documented as part of the cleaning validation process. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Documenting the Cleaning Process

1. For each cleaning process, the following details must be documented:
   • Equipment cleaned (e.g., filling machines, valves, pumps)
   • Cleaning procedure used (e.g., manual cleaning, automated cleaning)
   • Date and time of cleaning
   • Name of the operator performing the cleaning
2. The cleaning documentation should be maintained in the Cleaning Log (Annexure-1), and must be signed and dated by the operator and reviewed by the supervisor.
3. The cleaning process documentation should include any deviations from the established cleaning procedure, as well as any corrective actions taken.

5.2. Documenting Cleaning Validation Protocols

1. The cleaning validation protocol should be prepared before the validation activities are carried out. The protocol should include:
   • The cleaning process to be validated
   • Residue limits for active ingredients and cleaning agents
   • The sampling plan and method (e.g., surface swabbing, rinse water testing)
   • Test methods to be used for residue analysis
   • The schedule and personnel responsible for conducting the validation
2. The cleaning validation protocol should be reviewed and approved by the QA team before the validation begins. The protocol approval should be documented in the Cleaning Validation Protocol Approval Log (Annexure-2).

5.3. Documenting Sample Collection and Testing

1. Swab sampling or rinse water sampling should be performed according to the established sampling plan, and the following details must be documented:
   • Sampling location(s)
   • Type of sample collected (swab or rinse water)
   • Method of sample collection
   • Operator performing the sampling
   • Time and date of sampling
2. The sample collection documentation should be recorded in the Sampling Log (Annexure-3).
3. All analytical results should be recorded in the Cleaning Validation Results Report (Annexure-4), including residue levels, microbial contamination, and any deviations or non-conformities.

5.4. Documenting Deviation and Corrective Actions

1. If any deviations occur during the cleaning process or validation, they must be documented in the Deviation Log (Annexure-5). The Deviation Log should include:
   • The description of the deviation
   • The root cause analysis
   • The corrective actions taken
   • The date and time the deviation occurred
   • Names of the personnel involved in resolving the deviation
2. Corrective actions taken to resolve any deviations should be documented and tracked until completion. The corrective actions should also be recorded in the Corrective Action Log (Annexure-6).

5.5. Documenting Final Validation Results

1. Once the cleaning validation activities have been completed, a final Cleaning Validation Report (Annexure-7) should be prepared. The report should include:
   • Summary of the cleaning process and validation activities
   • Results of the residue analysis and microbial testing
   • Any deviations or issues encountered, along with corrective actions taken
   • Conclusion regarding the effectiveness of the cleaning process
2. The Cleaning Validation Report should be reviewed and approved by the QA team. Once approved, the report should be stored in the cleaning validation records.

5.6. Archiving and Retaining Documents

1. All documentation related to cleaning validation activities, including cleaning logs, sampling logs, deviation logs, and validation reports, should be retained for at least 5 years or as per regulatory requirements.
2. Documents should be stored in a secure, easily accessible location for future review and audits. All documents should be organized and cataloged for quick retrieval.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action

7. Documents

1. Cleaning Log (Annexure-1)
2. Cleaning Validation Protocol Approval Log (Annexure-2)
3. Sampling Log (Annexure-3)
4. Cleaning Validation Results Report (Annexure-4)
5. Deviation Log (Annexure-5)
6. Corrective Action Log (Annexure-6)
7. Cleaning Validation Report (Annexure-7)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• International Council for Harmonisation (ICH) Guidelines

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 Log

Equipment Cleaned	Cleaning Procedure	Date and Time	Operator	Supervisor Review
FILL-001	Manual Cleaning	06/02/2025	Rajesh Patel	Approved
FILL-002	Automated Cleaning	06/02/2025	Vikas Sharma	Approved

Annexure-2: Cleaning Validation Protocol Approval Log

Protocol ID	Approved By	Approval Date	Comments
CVP-001	Anjali Sharma	06/02/2025	Approved for validation

Annexure-3: Sampling Log

Sampling Point	Sample Type	Date and Time	Operator	Sample ID
Nozzle 1	Swab	06/02/2025	Rajesh Patel	Sample-001
Container 2	Rinse Water	06/02/2025	Vikas Sharma	Sample-002

Annexure-4: Cleaning Validation Results Report

Batch Number	Residue Level	Acceptance Criteria	Result	Corrective Action
Batch-001	Detergent 3 ppm	Less than 5 ppm	Pass	None

Annexure-5: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Assigned To	Status
DEV-12345	Residue above limit	Re-cleaned equipment	Rajesh Patel	Completed

Annexure-6: Corrective Action Log

Action ID	Action Description	Assigned To	Completion Date	Status
CA-78901	Adjusted cleaning procedure	Vikas Sharma	06/02/2025	Completed

Annexure-7: Cleaning Validation Report

Batch Number	Test Date	Residue Level	Acceptance Criteria	Result
Batch-001	06/02/2025	3 ppm	Less than 5 ppm	Pass

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated cleaning documentation procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures