Standard Operating Procedure for Line Clearance Before Manufacturing in Elixir Department
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/072/2025 |
| Supersedes | SOP/ELX/072/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To outline the procedure for line clearance in the Elixir Department before initiating batch manufacturing, ensuring the area, equipment, and materials are free from any previous batch residues, documents, and unrelated items.
2. Scope
This SOP is applicable to all manufacturing areas and equipment used in the preparation of elixirs, including mixing, transfer, and storage zones, prior to starting a new batch.
3. Responsibilities
- Production Operator:
- Perform preliminary checks of cleanliness and remove unrelated items.
- Production Supervisor:
- Conduct detailed area inspection and complete line clearance checklist.
- QA Officer:
- Verify line clearance, ensure compliance, and authorize start of batch by signing clearance form.
4. Accountability
The Production Manager is accountable for ensuring that line clearance is properly executed and documented before beginning any batch operation.
5. Procedure
5.1 Prerequisite
- Ensure completion of cleaning and
sanitization activities prior to line clearance.
Verify that all status labels are updated and area is under “CLEANED” condition.
5.2 Line Clearance Steps
- Remove all documents, labels, and product remnants of the previous batch.
- Ensure no raw materials, semi-finished products, or containers from previous batches are present.
- Check equipment cleanliness and availability of calibrated instruments.
- Ensure waste bins are empty and cleaned.
- Verify the availability of the correct batch manufacturing record (BMR) and materials for the next batch.
5.3 Documentation
- Complete the Line Clearance Checklist (Annexure-1) for each batch.
- Record the name, signature, and date of the production and QA personnel involved in the clearance.
- Submit the signed checklist to QA for archival along with BMR.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- BMR: Batch Manufacturing Record
- cGMP: Current Good Manufacturing Practice
7. Documents
- Line Clearance Checklist (Annexure-1)
- Line Clearance Tag (Annexure-2)
- BMR – Line Clearance Section
8. References
- 21 CFR Part 211.130 – Packaging and Labeling Control
- WHO GMP Guidelines – Production Area Requirements
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 Checklist
| Checklist Item | Status (Yes/No) | Remarks |
|---|---|---|
| All equipment cleaned and labeled | Yes | Verified visually |
| Previous batch documents removed | Yes | Disposed |
| Correct BMR present | Yes | ELX-1015 |
| Calibration of balances verified | Yes | Valid till 12/2025 |
Annexure-2: Line Clearance Tag
| Area | Equipment ID | Cleared By | Date | Status |
|---|---|---|---|---|
| Mixing Area | MXV-03 | Sunita Reddy | 11/04/2025 | CLEARED |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Added Tag Format and Checklist Fields | Process Clarity | QA Head |