Standard Operating Procedure for Equipment Line Clearance Before Drying in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/076/2025 |
| Supersedes | SOP/API/076/2022 |
| 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 standard procedure for conducting equipment line clearance before initiating drying operations to ensure cleanliness, prevent cross-contamination, and maintain GMP compliance.
2. Scope
This SOP is applicable to all drying equipment such as fluid bed dryers, tray dryers, vacuum ovens, and rotary dryers used for drying of APIs or intermediates in the API manufacturing area.
3. Responsibilities
- Production Operator: Verify equipment cleanliness and ensure the area is ready for drying.
- Production Supervisor: Conduct line clearance and fill the clearance checklist.
- QA Officer: Review line clearance records and authorize batch startup.
4. Accountability
The Production Head is accountable for execution of line clearance before drying. The QA Head is responsible for compliance review and documentation control.
5. Procedure
5.1 Pre-Start Inspection
- Ensure cleaning of equipment and surrounding area is completed as per SOP/API/074/2025 or applicable cleaning SOP.
- Check that the cleaning status label is affixed on the equipment indicating “CLEANED”, along with date and signature.
- Ensure that the previous product label or BMR-related paperwork has been removed from the area.
- Confirm that utensils, sampling tools, and containers used for previous batch have been removed.
5.2 Line Clearance Checks
- Use the “Drying Line Clearance Checklist” (Annexure-1) to verify:
- Correct product name and batch number
- Dryer equipment code and status
- Filters, trays, and contact surfaces are clean and free from residues
- No rejected, returned, or excess material from previous batch is present
- Drainage, exhaust systems, and AHU ducting are unobstructed and functioning
- Environmental parameters are within acceptable limits (RH and temperature)
- Cross-check cleaning records and ensure documentation is complete for previous product or batch.
- Verify that the “Under Maintenance” or “Do Not Use” tags are not present on any associated equipment.
5.3 QA Review and Authorization
- QA shall verify entries made in the checklist and inspect the equipment physically.
- Once verified, QA signs off the checklist and allows initiation of drying activity.
- Affix “LINE CLEARED” tag on the equipment with product name, batch number, date, and signatures.
5.4 Post-Line Clearance Control
- Ensure the drying equipment is started within 4 hours of clearance; if delayed, re-verification is mandatory.
- Maintain completed checklists in the BMR and make them available for internal or external audits.
6. Abbreviations
- SOP: Standard Operating Procedure
- API: Active Pharmaceutical Ingredient
- QA: Quality Assurance
- BMR: Batch Manufacturing Record
- AHU: Air Handling Unit
7. Documents
- Drying Line Clearance Checklist (Annexure-1)
- Cleaning Record of Drying Equipment
- Batch Manufacturing Record
8. References
- ICH Q7 – GMP for Active Pharmaceutical Ingredients
- EU GMP Chapter 5 – Production
- WHO TRS 986 Annex 2
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 Line Clearance Checklist
| Date | Batch No. | Dryer ID | Area Clean | Equipment Clean | Filters Checked | QA Verified |
|---|---|---|---|---|---|---|
| 13/04/2025 | API-20250413 | FBD-003 | Yes | Yes | Yes | Yes |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial SOP Release | Regulatory Requirement | QA Head |
| 13/04/2025 | 2.0 | Checklist Format and Timing Criteria Added | Audit Recommendation | QA Head |