Meeting the PIC/S Requirements for a Computerized System

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Lynn Archambault
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White Papers

GMP is important for manufacturers of active pharmaceutical ingredients (APIs), finished pharmaceuticals, or companies that provide research and clinical trial services to such manufacturers. The PIC/S GMP Guide (PE 009-11, March 2014) lays out the requirements for every step of the manufacturing process from raw material receipt through distribution, and provides specific guidance for different types of products: e.g. blood and plasma and veterinary medicines.



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