The Bulk Pharmaceuticals Task Force (BPTF)* has developed and published a Quality Agreement template. The quality agreement templatewas created to provide guidance for drafting agreements relating to the manufacture and release of drug substances regulated by the Food and Drug Administration. The template is based on the collective experience of industry members. "Manufacturers of active pharmaceutical ingredients are getting inundated with customers requesting quality agreements to meet FDA requirements," said BPTF Chairman Brant Zell of Cherokee Pharmaceuticals LLC. "In many cases, customers have different and conflicting requirements, which may not be practical or regulatory in nature, making the process both time consuming and a recipe for failure inside the API manufacturing quality system." Zell added that both manufacturers and customers win by using a harmonized quality agreement.
* BPTF is an industry trade organization for US manufacturers of active pharmaceutical ingredients, their intermediates and excipients. Created in 2002 as an affiliate organization of SOCMA (Society of Chemical Manufacturers and Affiliates), its primary objective is to seek clarification of current regulatory requirements and to interact with governmental agencies on emerging issues that may impact SOCMA members.
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发表于 2017-7-1 22:52:50
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