Procedure for Cleaning and Re-Starting Manufacturing Lines
| Department | Manufacturing/Production/Quality Assurance (QA)/Quality Control (QC)/Engineering |
|---|---|
| SOP No. | SOP/Ointment/200 |
| 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 a structured method for cleaning and re-starting manufacturing lines after batch completion or process interruptions, ensuring compliance with GMP standards.
2. Scope
This SOP applies to all personnel involved in cleaning, sanitization, and restarting manufacturing lines in the production facility.
3. Responsibilities
- Production Supervisor: Ensures proper cleaning and restart procedures are followed.
- Cleaning Personnel: Performs cleaning as per SOP.
- QA Officer: Verifies cleaning effectiveness.
- QC Analyst: Conducts swab tests to ensure no contamination.
- Engineering Team: Checks and certifies equipment readiness before restart.
4. Accountability
The Head of Manufacturing is accountable for ensuring all cleaning and restart processes adhere to GMP and regulatory guidelines.
5. Procedure
5.1 Cleaning Preparation
- Ensure production is halted before initiating cleaning.
- Gather approved cleaning agents and PPE (Personal Protective Equipment).
- Record preparation details in the **Cleaning Preparation Log (Annexure-1).**
5.2 Cleaning and Sanitization Process
- Remove any residual material and debris from surfaces.
- Use validated cleaning agents and follow contact time requirements.
- Wipe down all contact surfaces and ensure complete rinsing.
- Document cleaning details in the **Cleaning Execution Log (Annexure-2).**
5.3 Verification
and QC Testing
- Conduct swab sampling to verify no residual contamination.
- Ensure microbial limits meet regulatory requirements.
- Record results in the **QC Verification Report (Annexure-3).**
5.4 Re-Starting the Manufacturing Line
- Ensure all equipment is dried and inspected for cleanliness.
- Check calibration and readiness of machines before restart.
- Obtain QA clearance before beginning production.
- Document restart details in the **Manufacturing Line Restart Log (Annexure-4).**
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- PPE – Personal Protective Equipment
- SOP – Standard Operating Procedure
7. Documents
- Cleaning Preparation Log (Annexure-1)
- Cleaning Execution Log (Annexure-2)
- QC Verification Report (Annexure-3)
- Manufacturing Line Restart Log (Annexure-4)
8. References
- FDA Guidelines on Cleaning Validation
- ICH Q9 – Quality Risk Management
- WHO GMP Guidelines on Equipment Cleaning
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Cleaning Preparation Log
| Date | Batch No. | Cleaning Agent Used | Personnel Responsible | QA Approval |
|---|---|---|---|---|
| 08/02/2025 | OINT-10001 | Isopropyl Alcohol | John Doe | Approved |
Annexure-2: Cleaning Execution Log
| Date | Batch No. | Cleaning Completed (Yes/No) | Verified By | QA Approval |
|---|---|---|---|---|
| 08/02/2025 | OINT-10001 | Yes | QA Officer | Approved |
Annexure-3: QC Verification Report
| Date | Batch No. | Swab Test Result | Microbial Count | QA Approval |
|---|---|---|---|---|
| 08/02/2025 | OINT-10001 | Pass | Within Limits | Approved |
Annexure-4: Manufacturing Line Restart Log
| Date | Batch No. | Restart Approved By | Remarks | QA Approval |
|---|---|---|---|---|
| 08/02/2025 | OINT-10001 | Production Head | All checks cleared | Approved |
12. Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 08/02/2025 | 2.0 | Updated verification steps | Process Improvement | QA Head |
| 01/01/2024 | 1.0 | Initial SOP | New SOP Implementation | QA Head |