logs are updated in real time during the cleaning process and that any discrepancies are promptly reported to the QA team.

Maintenance Team: Responsible for ensuring that cleaning equipment is functioning properly and that cleaning tools and supplies are available as per the cleaning requirements.

4. Accountability

The Manufacturing Manager is accountable for ensuring that cleaning logs are created and maintained in compliance with this SOP. The overall compliance with this SOP is monitored by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Creating the Cleaning Log

1. Each cleaning activity must be documented in the designated cleaning log, which should include the following fields:
   • Equipment ID and name
   • Date and time of cleaning
   • Name of the cleaning personnel
   • Cleaning procedure performed (e.g., wash, rinse, sanitize)
   • Cleaning materials used (e.g., detergent, disinfectant)
   • Start and end time of the cleaning process
   • Any observations or deviations encountered during cleaning
2. The cleaning log should be legible, signed by the cleaning personnel, and dated.
3. For equipment that requires validation of the cleaning process, include the results of any validation testing (e.g., swab sampling, visual inspection). This data should be recorded in the cleaning log.

5.2. Updating the Cleaning Log

1. Ensure that the cleaning log is updated immediately after each cleaning activity. Delayed or incomplete entries may lead to discrepancies in documentation.
2. Cleaning logs should be kept in a secure, accessible location and be available for review by authorized personnel, including QA staff and regulatory auditors.
3. Any discrepancies or deviations from the standard cleaning procedure should be recorded in the log, including the corrective actions taken. A deviation report should be created if necessary (Annexure-1).

5.3. Reviewing Cleaning Logs

1. The QA team should review the cleaning logs periodically to ensure that all cleaning activities are performed according to the approved cleaning procedures and that all logs are complete and accurate.
2. If any discrepancies are identified, the QA team should investigate the cause and ensure that corrective actions are implemented. The investigation and actions taken should be documented in the Deviation Log (Annexure-2).

5.4. Archiving Cleaning Logs

1. Once the cleaning log is complete and reviewed, it should be archived for future reference. The log should be stored in a secure location for the required retention period, as per the company’s document retention policy.
2. Ensure that the archived logs are easily accessible for audit purposes and that they are organized in a manner that allows for efficient retrieval.
3. Cleaning logs should be retained for a minimum of 3 years or in accordance with regulatory requirements or company policies.

5.5. Reviewing and Updating Cleaning Procedures

1. Cleaning procedures should be reviewed periodically to ensure they remain effective and compliant with regulatory requirements. Any changes to cleaning procedures should be documented, and the updated procedures should be communicated to all relevant personnel.
2. If any issues are found during the review process, corrective actions should be implemented and documented in the Cleaning Procedure Update Log (Annexure-3).

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action
• BMR: Batch Manufacturing Record
• PCR: Product Control Record
• QC: Quality Control

7. Documents

1. Cleaning Log (Annexure-1)
2. Deviation Log (Annexure-2)
3. Cleaning Procedure Update Log (Annexure-3)

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
• ISO 9001 – Quality Management Systems

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 ID	Cleaning Procedure	Date and Time	Personnel	Materials Used	Observations
FM-001	Routine Cleaning	06/02/2025	Rajesh Patel	Detergent, Disinfectant	No Issues

Annexure-2: Deviation Log

Deviation ID	Description	Corrective Action	Responsible Person	Status
DEV-12345	Cleaning time exceeded	Revised cleaning procedure	Rajesh Patel	Completed

Annexure-3: Cleaning Procedure Update Log

Update ID	Update Description	Implemented By	Implementation Date
CPU-12345	Updated cleaning procedure for crimping machines	Rajesh Patel You said: Continue ChatGPT said: Here is the continuation of the SOP for Topic 159: SOP for Creating and Maintaining Cleaning Logs: html Copy Edit	Rajesh Patel	06/02/2025

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 procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures