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cGMP characteristics

characteristics of cGMP

QuestionAnswer
characteristic #1 of cGMP listed in 21 CFR, parts 210 and 211
characteristic #2 of cGMP enforced by the FDA
characteristic #3 of cGMP started in 1963 and revised/updated regularily
characteristic #4 of cGMP ensure quality standards to protect people from harmful drug products in the USA
characteristic #5 of cGMP apply to pharmaceutical manufacturing industry/ components finished products in USA market
characteristic # 6 of cGMP all activities require written procedures that are signed by the author and cosigned by a second person for a specified amount of time
Created by: oupharmshah
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