Standard Operating Procedure for Use of Cleaning Logbooks in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/176/2025 |
| Supersedes | SOP/ELX/176/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To establish a systematic procedure for the correct and consistent use of cleaning logbooks in the Elixir Department for documentation of all equipment cleaning activities in compliance with cGMP requirements.
2. Scope
This SOP is applicable to all cleaning logbooks maintained for manufacturing tanks, transfer lines, accessories, filters, and related equipment used in the Elixir Department.
3. Responsibilities
- Production Operator:
- Accurately record cleaning activity in the appropriate logbook immediately after task completion.
- QA Personnel:
- Verify completeness and accuracy of entries during routine checks.
- Ensure logbooks are reviewed and archived as per SOP.
- Production Supervisor:
- Ensure that logbooks are properly maintained and available at equipment locations.
4. Accountability
The Production Head is accountable for implementation and training on the procedure. The QA Head is responsible for compliance verification and archival of completed logbooks.
5. Procedure
5.1 General Instructions
- Use only approved and pre-numbered logbooks issued by QA.
- Logbooks must be bound and pages numbered. Loose sheets are not permitted.
- Entries shall be made with permanent ink (blue or black only).
- Do not use correction fluid. In case of errors, strike through with a single line, initial, and write the correction nearby.
5.2 Logbook Structure
Each logbook should contain the following sections:
- Equipment ID and Description
- Cleaning frequency (daily, batch-wise, weekly, etc.)
- Table for recording:
- Date and Time
- Cleaning Type (Product changeover, preventive, routine, etc.)
- Name of Product Processed
- Cleaning Performed By
- Verified By
- Remarks
5.3 Recording Procedure
- After cleaning, the operator must immediately fill in the entry in the relevant equipment logbook.
- QA or production supervisor must verify and countersign the entry.
- In case of multiple equipment in the same process train, ensure cross-reference to other logbooks.
5.4 Storage and Retrieval
- Maintain logbooks at or near the equipment location in a protected holder.
- Do not remove logbooks from the production area without written permission from QA.
- Once a logbook is completed, it must be closed, signed off, and sent to QA for archival.
- Retain archived logbooks for a minimum of 5 years or as per data retention policy.
5.5 Issuance and Control
- QA shall issue logbooks with control numbers and maintain a Logbook Issue Register.
- Logbooks shall be uniquely identified with:
- Department
- Equipment ID
- Logbook No.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- ID: Identification
7. Documents
- Cleaning Logbook Format (Annexure-1)
- Logbook Issue Register
8. References
- 21 CFR Part 211.180 – Records and Reports
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- WHO TRS 986 Annex 4 – Documentation Practices
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 Logbook Format
| Date | Equipment ID | Cleaning Type | Product Name | Cleaned By | Verified By | Remarks |
|---|---|---|---|---|---|---|
| 11/04/2025 | MXR-ELX-15 | Product Changeover | Elixir-C | Rajesh Kumar | Sunita Reddy | Visually Clean |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Clarified entry protocol and archival requirements | GMP Enhancement | QA Head |