Standard Operating Procedure for Line Clearance After Manufacturing in Elixir Department
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/112/2025 |
| Supersedes | SOP/ELX/112/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To define the procedure for conducting and documenting line clearance activities after the completion of elixir batch manufacturing to ensure that the area is free of previous batch materials, products, documents, and labels before initiating cleaning or next operation.
2. Scope
This SOP applies to all production lines, equipment, accessories, and areas used in the Elixir Department after completion of batch processing and prior to cleaning or next batch setup.
3. Responsibilities
- Production Operator:
- Remove used materials, clean the area preliminarily, and notify the supervisor.
- Production Supervisor:
- Perform and verify line clearance and complete documentation.
- QA Officer:
- Review line clearance documentation and approve the area for cleaning or next operation.
4. Accountability
The Head of Production is accountable for ensuring that proper line clearance is conducted, documented, and verified by QA in compliance with GMP standards.
5.
Procedure
5.1 Preparation
- After batch completion, remove:
- Remaining raw materials and packaging components
- Batch-specific documents
- Labels and tags from previous batch
- Close all open containers and transfer them to designated storage or disposal.
5.2 Visual Inspection
- Inspect the manufacturing area, including:
- Mixing tanks and agitators
- Transfer pipelines and hoses
- Working tables and instruments
- Ensure no traces of product, documents, or labels are present.
5.3 Line Clearance Documentation
- Record observations in the Line Clearance Checklist (Annexure-1).
- Production Supervisor signs off on each section once cleared.
- Forward the checklist to QA for verification and final approval.
5.4 QA Verification
- QA Officer inspects the area and ensures:
- No mix-up of materials
- All batch-related documents are removed
- No contamination or product remnants are visible
- Once satisfied, QA signs off and authorizes “LINE CLEARED” status.
- Affix a “LINE CLEARED” label with date, batch number, and signature.
5.5 Deviation Handling
- If any leftover material or label from the previous batch is found post-clearance, initiate a deviation report and conduct a root cause analysis.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- BMR: Batch Manufacturing Record
7. Documents
- Line Clearance Checklist (Annexure-1)
- Deviation Report (if applicable)
- Batch Manufacturing Record (BMR)
8. References
- 21 CFR Part 211.130 – Packaging and Labeling Control
- WHO TRS 986 – GMP 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
| Date | Batch No. | Area | Cleared By | Verified By (QA) | Remarks |
|---|---|---|---|---|---|
| 11/04/2025 | ELX-1048 | Mixing Room 2 | Rajesh Kumar | Sunita Reddy | No Issues |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Included deviation handling and labeling | GMP Compliance Improvement | QA Head |