Standard Operating Procedure for Maintaining Equipment Cleaning Logs in Gel Manufacturing
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/133/2025 |
| Supersedes | SOP/GM/133/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 09/06/2025 |
| Effective Date | 11/06/2025 |
| Review Date | 09/06/2027 |
1. Purpose
To describe the procedure for maintaining and documenting equipment cleaning logs for all equipment used in gel manufacturing to ensure traceability, compliance with GMP, and readiness for internal and external audits.
2. Scope
This SOP applies to all manufacturing and cleaning personnel involved in cleaning and documentation of cleaning
activities for all equipment used in the Gel Manufacturing Department.
3. Responsibilities
- Operators: Perform equipment cleaning and record details in the respective cleaning logbook.
- Production Supervisor: Verify entries and ensure compliance with documentation practices.
- QA Executive: Periodically review logbooks for completeness and GMP compliance.
4. Accountability
Head – Manufacturing and Head – Quality Assurance
5. Procedure
5.1 Cleaning Logbook Issuance
- QA shall issue a separate cleaning logbook for each equipment with a unique Equipment ID.
- The logbook shall be pre-numbered and recorded in the Logbook Issuance Register.
5.2 Log Entry Procedure
- Operators shall fill out the cleaning log immediately after cleaning is completed.
- Details to be entered include: Date, Time, Equipment Name, Equipment ID, Cleaning Type (Product Changeover/Campaign Cleaning), Product Name, Batch No., Cleaning Method (Manual/CIP), and Signature.
- Supervisor shall review the entry and countersign each completed record.
5.3 Record Verification
- QA shall verify at least one entry per equipment per week to ensure procedural compliance.
- Any discrepancies or missing entries shall be documented and investigated per deviation SOP.
5.4 Logbook Storage and Retention
- Completed logbooks shall be collected by QA, closed with remarks, and stored in the documentation archive room.
- Retention period: 5 years from date of last entry or as per regulatory requirements.
5.5 Handling of Corrections
- Any corrections shall be made with a single line strike-through, initialed, dated, and reason recorded.
- Use of correction fluid is strictly prohibited.
6. Abbreviations
- QA: Quality Assurance
- CIP: Clean-In-Place
- GMP: Good Manufacturing Practices
7. Documents
- Equipment Cleaning Logbook – Annexure-1
- Logbook Issuance Register
- Deviation Report (if applicable)
8. References
- Schedule M – Good Manufacturing Practices
- WHO TRS 986 – GMP Guidelines for Documentation
- 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
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: Equipment Cleaning Log Format
| Date | Equipment Name | Equipment ID | Cleaning Type | Product Name | Batch No. | Cleaning Method | Performed By | Reviewed By |
|---|---|---|---|---|---|---|---|---|
Revision History
| Revision Date | Revision No. | Change Description | Reason | Approved By |
|---|---|---|---|---|
| 01/05/2022 | 1.0 | Initial Issue | New SOP | QA Head |
| 09/06/2025 | 2.0 | Updated log format and sampling frequency | Annual Review | QA Head |