Implementation of hazard analysis and critical control points (HACCP) in Indian biopharmaceutical industries: A field study

People widely accept the HACCP principles as an effective approach to ensuring product safety. Internationally recognized, these principles serve as a tool for managing safety hazards in the manufacturing domain. HACCP is a crucial component in biopharmaceutical industries. It is vital in maintaining consumer safety, sustaining biopharmaceutical product quality, improving risk management, and promoting continuous improvement. This study revolves around the crucial domain of the HACCP system, which falls under Good Manufacturing Practices (GMPs), established by regulatory bodies such as the CDSCO (Central Drugs Standard Control Organization) and FDA (Food and Drug Administration). The methodology involved a cross-sectional survey-based questionnaire administered to 14 biopharmaceutical industries. Interviews with manufacturers were conducted through on-site visits and online modes. The present study showed strong adherence to HACCP procedures with a dedicated HACCP team ensuring hazard identification. It was observed that amending and updating the HACCP plan ensured its ongoing effectiveness. At the same time, documentation encompassed thorough records, including critical control points (CCPs), monitoring procedures, corrective actions, and verification activities. Additionally, the complexity of the procedures made maintaining the HACCP system a challenge. For instance, manufacturers must make substantial investments to adhere to the strict rules required for regulatory compliance. It was revealed that all surveyed biopharmaceutical industries followed CDSCO and the FDA guidelines. However, some industry officials anticipated solutions to streamline these standards for a more effective implementation of HACCP. Regulatory bodies provided guidance and expertise to the surveyed industries.