Speaker
Description
The pharmaceutical industry operates under strict regulatory frameworks to ensure that medicinal products meet the highest standards of quality, safety, and efficacy of the products1. Effective management of non-conformities in the pharmaceutical industry is essential for ensuring product quality, patient safety, and regulatory compliance.
While reporting of any nonconformity is mandatory, the key objective is identifying root causes and preventing recurrence. Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPA) are therefore fundamental elements of the pharmaceutical quality system2 as part of lifecycle management 3.
This study focuses on the most common tool used in Alkaloid AD Skopje, Ishikawa Fishbone Diagram and 5Whys, as root cause analysis as important and powerful methods for resolving cause in the investigations and defining appropriate corrective action. RCA and CAPA represent essential tools for managing non-conformities in the pharmaceutical industry and preventing their recurrence. Based on the performed root cause identification, CAIA is implemented through clearly defined actions, tracking, and effectiveness verification. Risk-based thinking ensures proportionality of investigations and actions 4.
The integration of RCA findings into CAPA strategies enables organizations to eliminate root causes effectively, prevent recurrence, and strengthen process robustness.
Keywords: Root cause analysis (RCA), Fishbone diagram (Ishikawa), 5 Whys, Corrective action/Improvement action (CAIA), Non - conformities
References:
- Eudralex The Rules Governing Medicinal Products in the European Union Volume 4, EU Guidelines for GMP for Medicinal Products for Human and Veterinary Use- Chapter 1, Pharmaceutical Quality System. 2013
- ICH Q10: Pharmaceutical quality system. 2008
- ICH Q8(R2): Pharmaceutical development. 2009
- ICH Q9(R1): Quality Risk Management. 2023