Standard Operating Procedure for Handling Deviations during Manufacturing
1) Purpose
The purpose of this SOP is to establish procedures for identifying, documenting, evaluating, and resolving deviations encountered during pharmaceutical manufacturing processes to ensure product quality and compliance.
2) Scope
This SOP applies to all personnel involved in the detection, assessment, and management of deviations within the pharmaceutical manufacturing facility.
3) Responsibilities
3.1 Production Operators
- Report deviations promptly and accurately to supervisors or QA personnel.
- Implement immediate corrective actions as necessary to mitigate impact.
3.2 Quality Assurance (QA) Personnel
- Investigate and evaluate deviations to determine root causes and potential impacts.
- Recommend and oversee implementation of corrective and preventive actions (CAPA).
4) Procedure
4.1 Deviation Reporting
- Identify and document deviations from approved procedures or specifications.
- Classify deviations based on severity and potential impact on product quality.
4.2 Initial Assessment
- Conduct preliminary assessment of deviation to determine immediate actions required.
- Implement interim measures to prevent recurrence of deviations during ongoing production.
4.3 Investigation and Root Cause Analysis
- Formulate investigation plan and assemble investigation team as needed.
- Perform root cause analysis using appropriate tools and methodologies.
4.4 Corrective and Preventive Actions (CAPA)
- Develop CAPA plans based on investigation findings and risk assessment.
- Implement CAPA actions and monitor effectiveness through verification and validation.
5) Abbreviations, if any
QA: Quality Assurance
CAPA: Corrective and Preventive Actions
6) Documents, if any
- Deviation Report Forms
- Investigation Reports
- CAPA Plans and Follow-up Reports
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