Procedure for Handling Deviation Reports
| Department | Quality Assurance (QA)/Quality Control (QC)/Production |
|---|---|
| SOP No. | SOP/Ointment/086 |
| 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 approach for handling, investigating, and documenting deviations in pharmaceutical manufacturing processes. Proper deviation management ensures compliance with Good Manufacturing Practices (GMP) and regulatory requirements while maintaining product quality.
2. Scope
This SOP applies to all personnel in the Quality Assurance (QA), Quality Control (QC), and Production departments responsible for identifying, reporting, investigating, and closing deviation reports in the manufacturing process.
3. Responsibilities
- Production Operator: Identifies and reports deviations observed during production.
- Production Supervisor: Investigates deviations and ensures corrective actions are taken.
- Quality Control (QC) Analyst: Evaluates deviations affecting product quality and performs necessary testing.
- Quality Assurance (QA) Officer: Reviews deviation reports, initiates corrective actions, and ensures compliance with regulatory standards.
- QA Manager: Approves the final deviation report and ensures preventive measures are implemented.
4. Accountability
The QA and Production Managers are accountable for ensuring that all deviations are properly recorded, investigated, and resolved in compliance with GMP and regulatory requirements.
5. Procedure
5.1 Identification of Deviations
- Deviations may occur in manufacturing, packaging, labeling, testing, or documentation.
- Common types of deviations
include:
Any observed deviation must be reported immediately to the Production Supervisor and QA department.
- Minor: Deviations with minimal impact on product quality.
- Major: Deviations that may impact product quality or regulatory compliance.
- Critical: Deviations that affect patient safety or lead to batch rejection.
5.2 Deviation Reporting
- Complete a Deviation Report Form with the following details:
- Date and time of occurrence
- Location and process step where the deviation occurred
- Detailed description of the deviation
- Immediate corrective action taken (if any)
- Submit the Deviation Report to the QA department for review.
5.3 Deviation Investigation
- QA assigns an investigator to assess the deviation.
- The investigation should determine:
- Root cause of the deviation
- Impact on product quality and safety
- Potential recurrence of the issue
- Conduct a risk assessment if the deviation affects product safety.
5.4 Corrective and Preventive Actions (CAPA)
- Based on the investigation findings, develop a Corrective and Preventive Action (CAPA) plan.
- Corrective actions should address the root cause of the deviation.
- Preventive measures should be implemented to prevent recurrence.
- Examples of CAPA include:
- Updating SOPs or training personnel
- Modifying equipment settings or processes
- Improving material handling procedures
5.5 Approval and Closure
- QA Manager reviews and approves the deviation report.
- Ensure all corrective actions are implemented before closing the deviation.
- Record the deviation closure date and store the report for audit purposes.
5.6 Documentation
- Maintain all deviation reports in the Deviation Log.
- Ensure traceability of deviations, investigations, and CAPA actions.
- QA must review deviation trends periodically for continuous improvement.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- CAPA – Corrective and Preventive Action
7. Documents
- Deviation Report Form (Annexure-1)
- Deviation Log (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- ICH Q9 – Quality Risk Management
- 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 Report Form
| Date | Batch Number | Process Step | Deviation Type | Root Cause | Corrective Action | Approved By |
|---|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Mixing | Major | Temperature fluctuation | Machine recalibrated | QA Officer |
| 02/02/2025 | OINT-102 | Filling | Minor | Volume variation | Operator re-trained | QA Officer |
Annexure-2: Deviation Log
| Date | Batch Number | Deviation Description | CAPA Implemented | Final Status | Verified By |
|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Mixing temperature deviation | Recalibration | Closed | QA Head |
| 02/02/2025 | OINT-102 | Volume discrepancy | Operator retraining | Closed | QA Head |