A Risk-Based Approach For Management Of Raw Material Suppliers In Pharmaceutical Industry

Risk management has been employed in pharmaceutical industry in recent years. Risk –based approach for management of raw material suppliers has been a crucial aspect in quality management system. This thesis provides an overview of regulatory requirement and methodologies of quality risk management in raw material management. A case study, using Pfizer as an example, of applying a risk-based approach for management of raw material suppliers in pharmaceutical industry was discussed including the risk management theory, methodology and analysis to identify, evaluate, and control/reduce the risks in an acceptable level. A quantitative risk assessment was conducted to identify potential risks of supplier to demonstrate the supply chain securities as well as patient safety after the implementation of appropriate risk mitigations. Furthermore, the risk-based approach facilitates resources planning and allocation by focusing on the suppliers with high risk, therefore improves management efficiency.This thesis provides pharmaceutical industry a clear instruction on risk-based quality management in raw material suppliers, which is a critical step in ensuring final product(market drug) safety. Following regulatory guidelines and through analysis of risk assessment, manufacturers will be able to understand better in terms of where is high risk area, therefore set up procedures to minimize the risks and ensure final product safety.