Procedure for Handling Interruptions During Ointment Manufacturing
| Department | Manufacturing/Production/Quality Assurance (QA)/Quality Control (QC)/Engineering |
|---|---|
| SOP No. | SOP/Ointment/199 |
| 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 approach for handling interruptions during ointment manufacturing to minimize product loss, maintain compliance with GMP standards, and ensure process integrity.
2. Scope
This SOP applies to manufacturing, production, quality assurance, and engineering personnel responsible for managing and documenting interruptions in ointment manufacturing.
3. Responsibilities
- Production Supervisor: Identifies and documents manufacturing interruptions.
- Process Operator: Ensures proper corrective actions are taken as per SOP.
- QA Officer: Assesses potential impact of interruptions on product quality.
- QC Analyst: Conducts necessary testing post-interruption.
- Engineering Team: Troubleshoots and resolves equipment or utility failures.
4. Accountability
The Head of Manufacturing is accountable for ensuring that all manufacturing interruptions are managed and documented as per GMP regulations.
5. Procedure
5.1 Identifying Types of Interruptions
- Classify interruptions into:
- Equipment Failures
- Power Failures
- Raw Material Shortages
- Environmental Conditions (e.g., temperature fluctuations)
- Document details in the **Interruption Report Log (Annexure-1).**
5.2 Immediate Actions for Handling Interruptions
- Pause the manufacturing process to prevent batch contamination.
- Notify the production supervisor and engineering team.
- Record immediate corrective measures in the **Corrective Action Log (Annexure-2).**
5.3 Investigating Root Causes
- Conduct root
cause analysis using tools such as **5 Whys** or **Fishbone Diagram**.
Identify if the issue is recurring or isolated.
Document findings in the **Root Cause Investigation Report (Annexure-3).**
5.4 Restarting the Manufacturing Process
- Perform **line clearance checks** before restarting.
- Ensure all equipment is recalibrated and functional.
- Verify batch integrity with QA before resumption.
- Record batch restart approval in the **Batch Restart Authorization Log (Annexure-4).**
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- SOP – Standard Operating Procedure
- OOS – Out of Specification
7. Documents
- Interruption Report Log (Annexure-1)
- Corrective Action Log (Annexure-2)
- Root Cause Investigation Report (Annexure-3)
- Batch Restart Authorization Log (Annexure-4)
8. References
- FDA Guidelines on Manufacturing Process Controls
- ICH Q9 – Quality Risk Management
- WHO GMP Guidelines for Process Deviations
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Interruption Report Log
| Date | Batch No. | Type of Interruption | Duration | QA Approval |
|---|---|---|---|---|
| 07/02/2025 | OINT-9001 | Equipment Failure | 30 mins | Approved |
Annexure-2: Corrective Action Log
| Date | Batch No. | Issue Identified | Corrective Action Taken | QA Approval |
|---|---|---|---|---|
| 07/02/2025 | OINT-9001 | Power Failure | Switched to backup power | Approved |
Annexure-3: Root Cause Investigation Report
| Date | Batch No. | Root Cause Identified | Analysis Performed | QA Approval |
|---|---|---|---|---|
| 07/02/2025 | OINT-9001 | Motor Overheating | 5 Whys Analysis | Approved |
Annexure-4: Batch Restart Authorization Log
| Date | Batch No. | Restart Approved By | Remarks | QA Approval |
|---|---|---|---|---|
| 07/02/2025 | OINT-9001 | QA Head | Batch integrity maintained | Approved |
12. Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 07/02/2025 | 2.0 | Updated handling procedures for major interruptions | Process Improvement | QA Head |
| 01/01/2024 | 1.0 | Initial SOP | New SOP Implementation | QA Head |