STEP-BY-STEP PROCEDURE
1. PURPOSE
To describe the steps for initiation, investigation, implementation, effectiveness check and closure of Corrective and Preventive Actions (CAPA) in QMS to ensure product quality and compliance with regulatory requirements.
2. SCOPE
This procedure applies to all CAPAs arising from all GxP activities within the organization including manufacturing, QC, QA, engineering, warehouse, packing, Labs and all support functions.
3. DEFINITIONS
Correction – Immediate action to eliminate a detected nonconformity.
Corrective Action – Action taken to eliminate the root cause of nonconformity and prevent recurrence.
Preventive Action – Action taken to eliminate the cause of a potential nonconformity other undesirable potential situation.
Root Cause – The fundamental cause of a problem.
Effectiveness Check – Evaluation to determine if the CAPA has been effective and the problem will not recur.
Recurrence – Reappearance of the same problem after CAPA closure.
3. DEFINITIONS
Correction – Immediate action to eliminate a detected nonconformity.
Corrective Action – Action taken to eliminate the root cause of nonconformity and prevent recurrence.
Preventive Action – Action taken to eliminate the cause of a potential nonconformity other undesirable potential situation.
Root Cause – The fundamental cause of a problem.
Effectiveness Check – Evaluation to determine if the CAPA has been effective and the problem will not recur.
Recurrence – Reappearance of the same problem after CAPA closure.
Critical / Major / Minor – Classification based on risk (Critical: High impact, Major: Medium impact, Minor: Low impact).
4. REGULATORY REFERENCES
WHO GMP Guidelines
FDA 21 CFR Part 211
PIC/S GMP Guide
ICH Q9 – Quality Risk Management
ICH Q10 – Pharmaceutical Quality System
Data Integrity Principles – ALCOA+
5. ROLES & RESPONSIBILITIES
QA – Overall ownership, review, approval and closure of CAPA.
Production – Provide input, implement actions.
QC – Provide analytical data, investigation support.
Engineering – Equipment related CAPAs, technical support.
Warehouse – Provide data related to material handling, storage.
Regulatory Affairs – Regulatory impact assessment and notifications.
System Administrator – User access, system configuration, audit trail.
CAPA Owner – Responsible for investigation, implementation and effectiveness.
6. SOURCES OF CAPA INITIATION
Deviations
OOS / OOT
Complaints
Audit observations
Self-inspections
Regulatory observations
Environmental monitoring trends
Validation failures
Data integrity incidents
Risk assessments
Supplier issues
Change controls
Note next to the list: Any event that impacts product quality, patient safety, or compliance.