THE DRUG SPECIFICATION-SETTING PROCESS
This article was originally published in The Gold Sheet
... is being reevaluated in the context of the new quality-by-design concepts and the more flexible regulatory paradigm they are targeting. At a recent FDA/PQRI workshop, regulators and industry focused on clinical relevancy, GMPs and the future of compendial standards in the search for how specifications can best assure that the product and process design is maintained without hindering manufacturing improvements. The advancing concepts of design space and process analytical technology are challenging FDA and USP to reassess the role that specifications play in their respective regulatory schemes. For USP, the issues raised about public standards and the way they are presented in the compendial monographs and general chapters are very much alive as the pharmacopeia enters its next quinquennial cycle.
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