Standard Operating Procedure for Cleaning Logs Documentation for Mixing Vessels in Gel Manufacturing
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/151/2025 |
| Supersedes | SOP/GM/151/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 09/06/2025 |
| Effective Date | 11/06/2025 |
| Review Date | 09/06/2027 |
1. Purpose
To define the procedure for documenting cleaning operations of mixing vessels used in the manufacturing of gel-based pharmaceutical formulations, ensuring data integrity, traceability, and GMP compliance.
2. Scope
This procedure is applicable to all mixing vessels, both fixed and mobile, used for gel manufacturing at the facility.
3. Responsibilities
- Production Operator: Performs the cleaning activity and records all required details in the cleaning logbook.
- Production Supervisor: Reviews and signs off on the cleaning records after verification.
- QA Executive: Performs random audits of cleaning logs and
verifies compliance.
4. Accountability
The Head – Manufacturing is accountable for the proper documentation, review, and retention of cleaning records for all mixing vessels.
5. Procedure
5.1 Cleaning Logbook Structure
- Use a bound logbook with pre-numbered pages labeled “Mixing Vessel Cleaning Log.”
- Include the following columns in the logbook:
- Date of cleaning
- Vessel ID
- Type of cleaning (Routine / Product Changeover / CIP / Manual)
- Cleaning procedure reference number
- Cleaning agent used
- Initials and signature of operator
- Verification by supervisor
5.2 Recording of Cleaning Activity
- After each cleaning activity, the operator shall record details in the cleaning logbook immediately using black permanent ink.
- Do not leave any columns blank. Use “NA” where not applicable.
- Strikethrough errors with a single line, counter-sign with date and reason.
5.3 Verification and Review
- The supervisor shall verify the cleaning status by physical inspection before signing the logbook.
- In case of discrepancies or unclear entries, escalate to QA immediately.
5.4 Retention and Archival
- Completed logbooks must be submitted to QA for archival after 1 month of usage or upon reaching full capacity.
- Logbooks must be stored in a secure document archive room for a minimum period of 5 years.
6. Abbreviations
- GMP: Good Manufacturing Practices
- CIP: Clean-In-Place
- QA: Quality Assurance
- NA: Not Applicable
7. Documents
- Mixing Vessel Cleaning Logbook – Annexure-1
- Cleaning SOP Reference (e.g., SOP/GM/045/2025)
- Cleaning Verification Checklist – Annexure-2
8. References
- Schedule M: Good Manufacturing Practices for Pharmaceuticals
- WHO TRS 986 Annex 2: Cleaning Validation Guidelines
- 21 CFR Part 211.67: Equipment Cleaning and Maintenance
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Jr. Production Chemist | QA Executive | Head – Manufacturing |
| Department | Gel Manufacturing | Quality Assurance | Manufacturing |
11. Annexures
Annexure-1: Mixing Vessel Cleaning Logbook Format
| Date | Vessel ID | Cleaning Type | SOP Ref No. | Cleaning Agent | Operator Signature | Supervisor Verification |
|---|---|---|---|---|---|---|
Annexure-2: Cleaning Verification Checklist
| Parameter | Compliant (Y/N) | Remarks |
|---|---|---|
| Residue-Free Surface | ||
| Proper Draining | ||
| Visual Cleanliness | ||
| Equipment Tag Updated |
Revision History
| Revision Date | Revision No. | Change Description | Reason | Approved By |
|---|---|---|---|---|
| 15/04/2022 | 1.0 | Initial issue | New equipment included | QA Head |
| 09/06/2025 | 2.0 | Formatted template, added verification checklist | Annual Review | QA Head |