7. Documents
- Line Clearance Checklist – Annexure-1
- Cleaning Records of Equipment – Annexure-2
- Calibration Records – Annexure-3
8. References
- WHO TRS 986 Annex 2: GMP for Pharmaceutical Production
- EU GMP Volume 4 Part 1: Chapter 5 Production
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: Line Clearance Checklist
| Checklist Point | Yes/No | Remarks | Checked By |
|---|---|---|---|
| Previous material removed | |||
| Cleaning done | |||
| Clean status labels present | |||
| Documents available |
Annexure-2: Cleaning Records of Equipment
| Equipment Name | Cleaning Date | Cleaned By | Verified By |
|---|---|---|---|
Annexure-3: Calibration Records
| Instrument | Calibration Date | Due Date | Status |
|---|---|---|---|
Revision History
| Revision Date | Revision No. | Change Description | Reason | Approved By |
|---|---|---|---|---|
| 03/04/2022 | 1.0 | Initial version | New SOP | QA Head |
| 09/06/2025 | 2.0 | Updated checklist and QA verification steps | Compliance update | QA Head |