HOLISTIC MARKET COMPLAINT INVESTIGATION IN PHARMACEUTICAL INDUSTRY: A FISHBONE DIAGRAM- BASED APPROACH

This paper outlines a comprehensive market complaint investigation methodology for the pharmaceutical industry, leveraging the fishbone (Ishikawa) diagram as a primary tool for systematic root cause analysis. Effective complaint handling is critical for ensuring product quality, patient safety, and regulatory compliance, adhering to guidelines from USFDA, MHRA, PIC/S, ICH, and WHO. We highlight the inherent challenges in investigating routine commercial market complaints, where superficial analysis often leads to misinterpretation of the root cause. This misdiagnosis results in ineffective Corrective and Preventive Actions (CAPA), perpetuating product defects and leading to repeated complaints, eroding consumer trust and inviting heightened regulatory scrutiny. The paper emphasizes the crucial need for a holistic investigation approach that transcends immediate symptoms to identify underlying systemic failures across all contributing factors (Man, Machine, Material, Method, Measurement, and Environment). Two detailed case studies illustrate this point: one involving a half-tablet in a blister pack and another concerning missing label information on a liquid product. Both cases demonstrate how focusing solely on apparent issues, like human error, can obscure the true mechanical or procedural deficiencies. By adopting a thorough, fishbone-driven methodology, pharmaceutical manufacturers can develop robust CAPA, prevent recurrence, and uphold the highest standards of pharmaceutical quality.