Standard Operating Procedure for Documentation in Manufacturing Logbooks in Elixir Production
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/083/2025 |
| Supersedes | SOP/ELX/083/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To establish a standardized and GMP-compliant procedure for accurate, timely, and legible documentation in manufacturing logbooks during elixir production processes.
2. Scope
This SOP applies to all personnel involved in manufacturing operations, including batch processing, equipment usage, cleaning, and material handling activities documented in logbooks in the Elixir Department.
3. Responsibilities
- Production Operator:
- Enter all activities in logbooks immediately after completion.
- Ensure entries are legible, signed, and dated with accurate time.
- Production Supervisor:
- Review logbook entries daily and verify compliance with batch records.
- QA Officer:
- Audit logbooks periodically and ensure records are traceable and GMP compliant.
4. Accountability
The Head of Production is accountable for ensuring that all logbooks are maintained as per regulatory standards and reflect true manufacturing operations.
5. Procedure
5.1 General Guidelines
- All entries must be made in indelible ink
(preferably blue).
No blank lines should be left between entries.
Each page must carry:
- Date
- Equipment or Process Identifier
- Product Name and Batch Number (if applicable)
5.2 Entry Requirements
- Entries must be factual, complete, and made in real time.
- Corrections must:
- Be made by drawing a single line through the incorrect entry
- Be initialed, dated, and justified (no erasures or white-outs)
- Include operator signature and time of activity.
- Use standard format for time entries (e.g., 09:45 AM, 03:30 PM).
5.3 Types of Logbooks
- Equipment Usage Log: Record equipment name, product processed, start/end times, cleaning status.
- Cleaning Log: Include tank ID, cleaning agent, method, and verification.
- Process Log: Document each step of batch manufacturing including mixing, heating, cooling, and volume adjustment.
5.4 Review and Archival
- Production Supervisor shall verify entries daily and sign at the bottom of each page.
- QA shall review completed logbooks monthly and maintain index sheets (Annexure-1).
- Completed logbooks must be archived in secure storage for a minimum of 5 years.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- GMP: Good Manufacturing Practice
7. Documents
- Logbook Index Sheet (Annexure-1)
- Daily Log Entry Sheet (Annexure-2)
- Logbook Reconciliation Register
8. References
- 21 CFR Part 211.180 – Records and Reports
- WHO TRS 986 – GMP for Pharmaceutical Products
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Logbook Index Sheet
| Logbook Type | Start Date | End Date | No. of Pages | Reviewed By | Remarks |
|---|---|---|---|---|---|
| Equipment Usage Log | 01/03/2025 | 10/04/2025 | 30 | Sunita Reddy | Completed |
Annexure-2: Daily Log Entry Sheet
| Date | Time | Activity | Batch No. | Operator | Remarks |
|---|---|---|---|---|---|
| 11/04/2025 | 09:45 AM | Transferred batch to storage tank | ELX-1022 | Rajesh Kumar | No deviation |
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 | Included Index Sheet and Archival Requirements | GMP Documentation Practice | QA Head |