Standard Operating Procedure for Line Clearance Before Start of Manufacturing in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/040/2025 |
| Supersedes | SOP/API/040/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To define the procedure for conducting line clearance before the initiation of any API manufacturing batch to ensure equipment, materials, documentation, and area are clean, ready, and free from remnants of previous processes or documents.
2. Scope
This SOP is applicable to all production areas and equipment in the API manufacturing facility where line clearance is a prerequisite to beginning batch production.
3. Responsibilities
- Production Personnel: Ensure cleanliness and readiness of equipment and materials.
- QA Personnel: Verify and approve line clearance checklist before batch start.
- Area Supervisor: Coordinate readiness and ensure compliance before QA intimation.
4. Accountability
The Production Head is accountable for execution of the line clearance process. QA Head is responsible for verification and approval of line clearance records.
5. Procedure
5.1 Pre-Line Clearance Checks by Production
- Ensure all cleaning activities are completed and documented as per the respective cleaning SOP.
- Confirm that the area is free from:
- Previous batch materials
- Labels or tags
- Documents or printouts not related to the new batch
- Verify equipment calibration is current and status tags are affixed.
- Ensure availability of raw materials, BMR, and utilities (air, vacuum, nitrogen, water).
- Intimate QA for clearance and fill out “Line Clearance Request Form” (Annexure-1).
5.2 Line Clearance by QA
- QA personnel shall physically inspect the area and equipment using the “Line Clearance Checklist” (Annexure-2).
- Verify cleanliness of:
- Reactor interiors and exteriors
- Sampling ports, transfer lines, filters
- Platform, floors, walls, tables, trolleys
- Cross-check presence and correctness of:
- BMR and product labels
- Material status labels
- Calibration status tags
- Sign and approve the checklist with date and time.
- Label the area and equipment as “Ready for Use.”
5.3 Documentation and Recordkeeping
- Ensure the completed checklist is attached to the BMR and retained for QA review.
- Any discrepancies must be resolved before production initiation.
- QA to maintain records of line clearance logs and trend analysis.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- BMR: Batch Manufacturing Record
7. Documents
- Line Clearance Request Form (Annexure-1)
- Line Clearance Checklist (Annexure-2)
- Line Clearance Log (Annexure-3)
8. References
- ICH Q7 – GMP for Active Pharmaceutical Ingredients
- 21 CFR Part 211 – Subpart D & F
- WHO GMP Guide for APIs – Section 6
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Line Clearance Request Form
| Date | Batch No. | Area | Requested By | Remarks |
|---|---|---|---|---|
| 13/04/2025 | API-202505 | Reactor Bay-1 | Ready for QA check |
Annexure-2: Line Clearance Checklist
| Item | Status (Y/N) | Remarks |
|---|---|---|
| Previous batch labels removed | Y | Verified |
| Equipment cleaned and labeled | Y | Tag affixed |
| Area free of material remnants | Y | Complies |
Annexure-3: Line Clearance Log
| Date | Batch No. | Area | QA Verified By | Status |
|---|---|---|---|---|
| 13/04/2025 | API-202505 | Reactor Bay-1 | Cleared |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial Issue | GMP Requirement | QA Head |
| 13/04/2025 | 2.0 | Checklist and Form Revised | Compliance Update | QA Head |