Risk management deals with planning for, and reacting to, hazard or loss. The regulatory authorities are focusing on the issues associated with establishing alternative sources of raw materials, especially as they are noticing a number of related quality problems in biopharmaceutical manufacturing. Supply chain management for critical raw materials used in biopharmaceutical manufacturing is an appropriate subject for risk management. This paper analyzes five important areas in risk management as it applies to the supply chain for critical raw materials…
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