Critical materials and suppliers are selected early in development. By the time Technology Transfer occurs for commercialization, it is often too late to make changes to these critical components without having to do additional testing or even repeating clinical trials. Regulatory authorities have made securing the supply chain a priority and have promised serious repercussions for companies and their management who do not manage risks to the supply chain. We propose developing a strategy for the selection of raw materials and components and their suppliers early in the development cycle. The strategy should be based on risk management principles and the needs and demands of the commercial market. The strategy would consider the unique attributes of the material and suppliers balanced against the potential risks that may be encountered when manufacturing for the commercial market.
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March 20, 2018
Smart Pharmaceutical Consulting Teams up with John Assaraf and One Coach to Develop Enhanced Consulting Services for the Bioscience Industry
May 20, 2009
January 8, 2010
Smart Pharmaceutical Consulting has made a major contribution to our manufacturing strategy and how we plan to operate our plant in the future.