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- W777740367 abstract "This research details the FDA's quality systems methodology used in its inspection of biopharmaceutical manufacturers in the time period between 2003 and 2009. It analyzes the violations specified in FDA site inspection warning letters, reviewing their frequency and specificity. This analysis is an exploration into FDA activity in this sector, focusing particularly on finished pharmaceuticals, and serves as an initial evaluation of the FDA’s performance. In addition, the study pays particular attention to whether the FDA’s risk methodology has enhanced the overall inspection process and increased its quality assurance." @default.
- W777740367 created "2016-06-24" @default.
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- W777740367 date "2014-06-17" @default.
- W777740367 modified "2023-10-17" @default.
- W777740367 title "FDA’s Quality Systems Methodology at Pharmaceutical Manufacturing Sites" @default.
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- W777740367 doi "https://doi.org/10.58729/1941-6687.1154" @default.
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