🛠 Standard Operating Procedure (SOP) for CAPA Management
1. Introduction
Corrective and Preventive Action (CAPA) ensures identification, investigation, and elimination of root causes of quality issues. CAPA supports continuous improvement, regulatory compliance, and prevention of recurrence in accordance with ICH Q10, WHO GMP, US FDA 21 CFR 211, and EU GMP.
2. Purpose
To define a systematic procedure for initiation, investigation, implementation, effectiveness verification, and closure of CAPA to:
- Eliminate root causes of quality issues
- Prevent recurrence of nonconformities
- Improve product quality and patient safety
3. Scope
This SOP applies to all CAPAs initiated due to:
- Deviations (planned or unplanned)
- Out of Specification (OOS) / Out of Trend (OOT)
- Internal and external audits
- Market complaints
- Regulatory inspection observations
- Quality risk management activities
4. Responsibilities
- CAPA Initiator: Identify issue and initiate CAPA.
- Investigator: Perform root cause analysis.
- Department Head: Ensure CAPA implementation.
- Quality Assurance (QA): Review, approve, monitor, and close CAPA.
- Senior Management: Review CAPA trends and effectiveness.
5. Procedure
5.1 CAPA Identification & Initiation
- Initiate CAPA upon identification of a significant quality issue.
- Sources include deviations, OOS/OOT, audits, complaints, inspections, trends.
- Complete CAPA initiation form with issue description.
- QA assigns a unique CAPA number and logs it in CAPA register.
5.2 Preliminary Assessment & Classification
- QA assesses severity and impact on product quality/patient safety.
- CAPA classified as Critical, Major, or Minor.
- High-risk CAPAs escalated to senior management.
- Define target timelines based on criticality.
5.3 Investigation & Root Cause Analysis
- Investigator assigned by QA.
- Root cause analysis using approved tools (5-Why, Fishbone).
- Support conclusions with objective evidence.
- Immediate corrective actions implemented if needed.
- QA approves root cause before proceeding.
5.4 CAPA Action Plan
- Corrective actions address root cause; preventive actions prevent recurrence.
- Specify responsibility, timeline, and measurable outcomes for each action.
- QA approval required before implementation.
5.5 CAPA Implementation
- Implement CAPA actions per approved plan.
- Changes affecting GMP systems follow Change Control.
- Document and justify any delays.
- QA monitors implementation progress.
5.6 CAPA Effectiveness Verification
- Conduct effectiveness checks using audits, trend analysis, re-testing, or performance monitoring.
- Ineffective CAPAs are re-opened and re-investigated.
5.7 CAPA Closure
- QA verifies completion and effectiveness of actions.
- Review supporting documents.
- Formally close CAPA; archive records as per retention policy.
5.8 Trending & Management Review
- Trend CAPA data and review during Management Review.
- Recurring issues trigger systemic improvements.
6. References
- ICH Q10 – Pharmaceutical Quality System
- WHO GMP Guidelines
- US FDA 21 CFR Part 211
- EU GMP Part I
7. Abbreviations
- CAPA: Corrective and Preventive Action
- QA: Quality Assurance
- OOS: Out of Specification
- OOT: Out of Trend
- GMP: Good Manufacturing Practice
- RCA: Root Cause Analysis
8. Annexures
Annexure 1: CAPA Initiation Form
| CAPA Number | |
| Date of Initiation | |
| Initiating Department | |
| Source of CAPA | Deviation / OOS / Audit / Complaint / Inspection / Trend |
| Description of Issue | |
| Immediate Action Taken (if any) | |
| Initial Risk Assessment | Low / Medium / High |
| Initiated By (Name & Sign) |
Annexure 2: CAPA Register
| CAPA No. | Initiation Date | Source | Department | Criticality | Target Date | Status | QA Closure Date |
|---|---|---|---|---|---|---|---|
| Minor / Major / Critical | Open / Closed |
Annexure 3: Root Cause Analysis (RCA)
| CAPA Number | |
| Problem Statement | |
| Investigation Tool Used | 5-Why / Fishbone / Other |
| Identified Root Cause | |
| Supporting Evidence | |
| Investigator Name & Sign | |
| QA Review & Approval |
Annexure 4: CAPA Effectiveness Check
| CAPA Number | |
| CAPA Action Implemented | |
| Effectiveness Check Method | Audit / Trend / Review / Test |
| Evaluation Results | |
| CAPA Effective? | Yes / No |
| Reviewed By (QA) | |
| Date of Closure |
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