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发表于 2022-4-3 14:08:39
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本帖最后由 厕所所长 于 2022-4-3 13:48 编辑
https://www.ivtnetwork.com/sites ... ng%20Validation.pdf
BTW: Although public distribution of ‘‘Human Drug CGMP Notes’’ ended in 2003, and the document was circulated only within FDA from 2001 to 2003 (but was available through FOIA), the guidances offered the drug industry advice on complying with the drug CGMPs, and we have retained the guidances on our Internet site. In other words, the drug CGMP regulations did not have to be as ‘‘prescriptive’’ because the drug industry learned about our interpretations or expectations of the drug CGMPs through guidance.
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