Procedure for Packing Line Clearance
| Department | Packaging/Quality Assurance (QA)/Production |
|---|---|
| SOP No. | SOP/Ointment/096 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for packing line clearance to ensure that packaging operations are conducted in a clean, contamination-free, and organized manner in compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all personnel in the Packaging, Quality Assurance (QA), and Production departments involved in conducting line clearance before, during, and after packaging operations.
3. Responsibilities
- Packaging Operator: Ensures proper clearance of materials and equipment before starting new batches.
- Packaging Supervisor: Conducts line clearance checks and records observations.
- Quality Assurance (QA) Officer: Verifies and approves line clearance before the start of packaging.
- QA Manager: Ensures compliance with GMP and approves final line clearance documentation.
4. Accountability
The QA and Packaging Managers are accountable for ensuring line clearance is conducted before every new packaging batch.
5. Procedure
5.1 Pre-Packaging Line Clearance
- Ensure that the packing area is free of any remnants from the previous batch.
- Check that no unused materials, labels, or packaging components are left from prior operations.
- Verify that all equipment is cleaned and in proper working condition.
5.2 Verification of Packaging Materials
- Ensure
that the correct batch-specific packaging materials are available.
Verify that the batch number, expiry date, and product details on labels and cartons are correct.
Check that tamper-evident seals and barcodes (if applicable) are available.
5.3 Equipment Readiness
- Ensure that all machines (e.g., sealing, labeling, coding) are calibrated and ready for use.
- Verify that the printing machine settings are correctly configured.
- Perform a test run of the packaging line to confirm smooth operation.
5.4 QA Approval and Documentation
- QA must conduct a final inspection before approving line clearance.
- Record line clearance details in the Packing Line Clearance Log.
- Only after QA approval can the packaging process begin.
5.5 Post-Packaging Line Clearance
- Ensure that all unused packaging materials are returned to the designated storage area.
- Remove any product residues and clean the packing line thoroughly.
- QA must verify and approve post-packaging clearance before releasing the line for the next batch.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BPR – Batch Packaging Record
7. Documents
- Packing Line Clearance Checklist (Annexure-1)
- Packing Line Clearance Approval Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- ICH Q10 – Pharmaceutical Quality System
- USP <41> – Weights and Balances
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Packing Line Clearance Checklist
| Date | Batch Number | Packaging Component | Cleared By | Verified By | Remarks |
|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Labels, Cartons | Packaging Operator | QA Officer | Compliant |
| 01/02/2025 | OINT-102 | Sealing Machine | Packaging Operator | QA Officer | Compliant |
Annexure-2: Packing Line Clearance Approval Report
| Date | Batch Number | Packing Line Status | Verified By | Approval Status |
|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Cleared | QA Manager | Approved |
| 02/02/2025 | OINT-102 | Cleared | QA Manager | Approved |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |