Procedure for Handling Deviations in Ointment Manufacturing
| Department | Production/Quality Assurance (QA)/Quality Control (QC) |
|---|---|
| SOP No. | DM-030 |
| 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 identifying, documenting, investigating, and resolving deviations in ointment manufacturing. Proper deviation management ensures compliance with GMP standards and prevents potential product quality issues.
2. Scope
This SOP applies to all personnel involved in the ointment manufacturing process, including production, quality control (QC), and quality assurance (QA) teams.
3. Responsibilities
- Production Supervisor: Identifies and reports deviations in the manufacturing process.
- QA Personnel: Reviews deviations, initiates investigations, and recommends corrective actions.
- QC Analyst: Conducts testing and verification of affected products.
- Engineering Team: Assists in investigating equipment-related deviations.
4. Accountability
The QA Manager is accountable for ensuring that all deviations are recorded, investigated, and resolved as per GMP standards.
5. Procedure
5.1 Types of Deviations
- Minor Deviation: A deviation that does not affect product quality or GMP compliance.
- Major Deviation: A deviation that impacts product quality, safety, or compliance.
- Critical Deviation: A serious deviation that leads to product rejection or regulatory non-compliance.
5.2 Identification and Reporting
- Any personnel detecting a deviation must report it immediately to the Production Supervisor.
- The
deviation must be documented in the Deviation Log with details such as batch number, description, and date.
The QA team must classify the deviation based on severity.
5.3 Investigation of Deviations
- QA will assign an investigation team to analyze the deviation.
- Root cause analysis (RCA) must be conducted using tools such as:
- 5-Why Analysis
- Fishbone Diagram
- Failure Mode and Effects Analysis (FMEA)
- Determine whether the deviation affects product quality or safety.
- Document investigation findings in the Deviation Investigation Report.
5.4 Corrective and Preventive Actions (CAPA)
- Corrective Action: Immediate measures to correct the deviation.
- Preventive Action: Long-term measures to prevent recurrence.
- QA must approve CAPA plans before implementation.
5.5 Documentation and Approval
- Record all deviation details in the Deviation Log.
- QA must approve all deviations before batch release.
- For critical deviations, a detailed report must be submitted to regulatory authorities if required.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- RCA – Root Cause Analysis
- CAPA – Corrective and Preventive Actions
7. Documents
- Deviation Log (Annexure-1)
- Deviation Investigation Report (Annexure-2)
- CAPA Report (Annexure-3)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- 21 CFR Part 211 – Current Good Manufacturing Practices
- ICH Q10 Pharmaceutical Quality System
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Deviation Log
| Date | Batch Number | Deviation Type | Description | Reported By | Verified By |
|---|---|---|---|---|---|
| 01/02/2025 | DM-001 | Minor | Mixing time exceeded by 2 minutes | John Doe | QA Officer |
| 02/02/2025 | DM-002 | Major | Temperature fluctuation during cooling | Jane Smith | QA Officer |
Annexure-2: Deviation Investigation Report
| Date | Batch Number | Root Cause | Impact on Quality | Investigation By | Final Decision |
|---|---|---|---|---|---|
| 01/02/2025 | DM-001 | Operator error | No impact | QA Team | Approved |
| 02/02/2025 | DM-002 | Equipment malfunction | Requires reprocessing | QA Team | Rework |
Annexure-3: CAPA Report
| Date | Batch Number | Corrective Action | Preventive Action | Implemented By | Verified By |
|---|---|---|---|---|---|
| 01/02/2025 | DM-001 | Retraining of staff | Revised SOP | Production Team | QA Officer |
| 02/02/2025 | DM-002 | Repaired cooling system | Periodic maintenance schedule | Engineering | QA Officer |
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 |