Standard Operating Procedure for Maintenance of Drying and Milling Logs in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/080/2025 |
| Supersedes | SOP/API/080/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To establish a standardized procedure for the recording, review, and control of drying and milling logs to ensure complete traceability of product processing, compliance with cGMP guidelines, and data integrity.
2. Scope
This SOP applies to all drying and milling operations conducted in the API manufacturing department and covers manual as well as electronic log maintenance, including
Fluid Bed Dryers, Tray Dryers, Jet Mills, and Pin Mills.
3. Responsibilities
- Production Operator: Accurately record all drying and milling parameters in the logbook in real-time.
- Production Supervisor: Review and verify entries for completeness and correctness.
- QA Department: Periodically audit logbooks and ensure adherence to data integrity standards.
4. Accountability
The Production Head is accountable for ensuring accurate and timely documentation. QA Head is responsible for maintaining and reviewing log control systems.
5. Procedure
5.1 Types of Logs Maintained
- Drying Log: Records related to FBD, tray dryer, vacuum dryer, etc.
- Milling Log: Records of jet milling, hammer milling, or pin milling activities.
5.2 Logbook Format and Control
- Use only QA-approved, pre-numbered, bound logbooks or validated electronic systems.
- Each logbook should have:
- Equipment name and ID
- Logbook number
- Index of pages
- Issued by QA with issuance date
5.3 Recording Entries
- Make entries in permanent ink with date and signature.
- Do not use correction fluids. For corrections, strike through with a single line, initial, and date.
- Record the following parameters:
- Date and time of operation
- Batch number and product name
- Start and end time of drying/milling
- Temperature, RPM, screen size, LOD, mesh number
- Remarks if abnormality observed
5.4 Review and Verification
- Supervisor must verify all entries at the end of each shift and sign off on each page.
- QA should review logs weekly and document any discrepancies observed.
- Cross-check BMR entries against logs for accuracy during batch documentation review.
5.5 Archival and Retention
- Once a logbook is completed, submit it to QA for closure and archival.
- Logs must be retained for a minimum of 5 years or as per regulatory/customer requirements.
- Electronic logs must be backed up and access-controlled as per 21 CFR Part 11 standards.
6. Abbreviations
- SOP: Standard Operating Procedure
- FBD: Fluid Bed Dryer
- QA: Quality Assurance
- LOD: Loss on Drying
- BMR: Batch Manufacturing Record
- RPM: Revolutions Per Minute
7. Documents
- Drying and Milling Logbook (Annexure-1)
- Logbook Issue Register
- Batch Manufacturing Record
8. References
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
- ALCOA+ Guidelines for Data Integrity
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Drying and Milling Logbook Format
| Date | Equipment ID | Batch No. | Operation Type | Start Time | End Time | Parameter (Temp/RPM) | Remarks | Operator |
|---|---|---|---|---|---|---|---|---|
| 13/04/2025 | FBD-002 | API-20250413 | Drying | 10:00 | 11:15 | 70°C | LOD achieved | |
| 13/04/2025 | JM-003 | API-20250413 | Milling | 13:00 | 14:00 | 6000 RPM | Uniform size |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial SOP Release | Compliance Requirement | QA Head |
| 13/04/2025 | 2.0 | Updated to include electronic log format and ALCOA+ alignment | Audit Observation | QA Head |