Standard Operating Procedure for Handling Deviations during Manufacturing
1) Purpose
The purpose of this SOP is to establish procedures for identifying, documenting, evaluating, and managing deviations from established manufacturing processes to ensure product quality and compliance.
2) Scope
This SOP applies to all personnel involved in manufacturing operations within the pharmaceutical manufacturing facility.
3) Responsibilities
3.1 Production Operators
- Report deviations promptly to supervisors or quality personnel.
- Take appropriate actions to mitigate immediate risks.
3.2 Quality Assurance (QA) Personnel
- Investigate deviations to determine root cause and potential impact on product quality.
- Review and approve deviation reports and corrective actions.
4) Procedure
4.1 Deviation Identification
- Recognize and document any deviation from approved procedures or specifications.
- Initiate a deviation report for further investigation.
4.2 Evaluation and Risk Assessment
- Assess the impact of the deviation on product quality and patient safety.
- Determine the urgency and extent of corrective actions required.
4.3 Corrective and Preventive Actions (CAPA)
- Implement immediate corrective actions to address the deviation’s effects.
- Develop and implement preventive actions to prevent recurrence of similar deviations.
4.4 Documentation and Review
- Document all investigation findings, actions taken, and approvals.
- Review and close deviation reports after verifying effectiveness of corrective actions.
5) Abbreviations, if any
SOP: Standard Operating Procedure; QA: Quality Assurance; CAPA: Corrective and Preventive Actions
6) Documents, if any
- Deviation Report Form
- CAPA Plan and Documentation
- Root Cause Analysis Report
7) Reference, if any
ICH Q9: Quality Risk Management
FDA Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
8) SOP Version
Version 1.0