Procedure for Line Clearance Before Production
| Department | Quality Assurance (QA)/Production |
|---|---|
| SOP No. | SOP/Ointment/082 |
| 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 establish a standardized procedure for performing line clearance before the start of production in the ointment manufacturing process. Line clearance ensures that the production area and equipment are free from any materials, documents, or residues from the previous batch, preventing cross-contamination and mix-ups.
2. Scope
This SOP applies to all personnel in the Production and Quality Assurance (QA) departments responsible for performing and verifying line clearance before the initiation of a new batch in ointment manufacturing.
3. Responsibilities
- Production Operator: Performs physical cleaning and removes unnecessary items from the production area.
- Production Supervisor: Ensures that line clearance activities are completed and documented properly.
- Quality Assurance (QA) Officer: Verifies the effectiveness of line clearance and provides final approval.
- Quality Assurance (QA) Manager: Reviews and ensures compliance with GMP guidelines before approving production startup.
4. Accountability
The QA and Production Managers are accountable for ensuring that line clearance is performed according to GMP standards and documented properly.
5. Procedure
5.1 Pre-Clearance Checks
- Ensure that the previous batch has been completed and all leftover materials have been removed.
- Verify that any rejected, quarantined, or unused materials are stored properly.
- Ensure that used equipment is cleaned and documented as per the cleaning SOP.
- Check that the production area is free from unwanted documents, tags, or labels.
5.2 Equipment Inspection
- Confirm that all machines are clean and in operational condition.
- Check calibration records of critical equipment (e.g., mixers, filling machines).
- Verify that all required tools and accessories are available.
5.3 Raw Material and Packaging Material Verification
- Confirm that only QA-approved raw materials and packaging components are present.
- Ensure that the correct labels and batch records are available.
- Verify that packaging material is not mixed with previous batches.
5.4 Environmental Conditions
- Ensure temperature and humidity levels are within specified limits.
- Check air filtration systems and ensure proper airflow.
- Verify that the production area meets cleanliness requirements.
5.5 Documentation and Approval
- Record all line clearance checks in the Line Clearance Log.
- QA personnel must verify and approve the line clearance checklist.
- Only after QA approval can the production process be initiated.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BMR – Batch Manufacturing Record
7. Documents
- Line Clearance Log (Annexure-1)
- Line Clearance Approval Form (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- USP <1072> – Disinfection and Cleaning of Equipment
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 Log
| Date | Batch Number | Production Area | Equipment Status | Material Check | Environmental Check | Verified By |
|---|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Mixing Room | Clean | Approved | Within Limits | QA Officer |
| 02/02/2025 | OINT-102 | Filling Room | Clean | Approved | Within Limits | QA Officer |
Annexure-2: Line Clearance Approval Form
| Date | Batch Number | Area Clearance Completed | Final Approval Status | Approved By |
|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Yes | Approved | QA Head |
| 02/02/2025 | OINT-102 | Yes | Approved | QA Head |
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 |