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CAPA Implementation: A Structured Approach in Irish Pharma.
Report
CAPA Implementation: A Structured Approach in Irish Pharma
Introduction
Corrective and Preventive Action (CAPA) is a structured method to identify, investigate, and resolve quality issues. It plays a vital role in pharmaceutical manufacturing, ensuring that deviations do not compromise product quality.
CAPA Process Steps
🔹 Problem Identification – Detect deviations, audit findings, or complaints.
🔹 Root Cause Analysis (RCA) – Using Fishbone Diagrams, 5-Whys, and Failure Mode and Effects Analysis (FMEA).
🔹 Implementation of Corrective Action – Process optimization, SOP updates, or equipment calibration.
🔹 Preventive Action – Establishing risk-based monitoring and training programs.
Case Study:
A CAPA Resolution in an Irish Pharmaceutical Plant
• An Irish manufacturer faced frequent sterility failures in injectable product lines. RCA revealed poor operator aseptic techniques. The CAPA plan introduced enhanced training programs, stricter gowning protocols, and routine monitoring. Within six months, sterility failures reduced by 75%.
👉 Contribution:
I have reviewed CAPA frameworks, ensuring that risk management aligns with EMA and HPRA regulations, improving pharma quality systems.
Corrective and Preventive Action (CAPA) identifies, investigates, and resolves quality issues to prevent deviations that compromise product quality. This project reviews CAPA frameworks, emphasizing RCA techniques, corrective action implementation, and preventive measures.