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1949stone

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[资源] WHO-Good manufacturing practice (GMP)

Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, which may broadly be categorized in two groups: cross contamination/mix-ups and false labelling. Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy; for this reason, risk assessment has come to play an important role in WHO quality assurance guidelines.

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附件 1 : ICH_Q7-IWG_QA_v5_0_14Apr2015_FINAL_for_publication_17June2015.pdf

2016-11-20 21:28:16, 328.42 K

附件 2 : TRS863Annex7.pdf

2016-11-20 21:28:21, 551.41 K

附件 3 : TRS885Annex5.pdf

2016-11-20 21:28:30, 998.14 K

附件 4 : TRS908Annex3.pdf

2016-11-20 21:28:31, 92.82 K

附件 5 : TRS908Annex7.pdf

2016-11-20 21:28:33, 100.91 K

附件 6 : TRS937Annex3.pdf

2016-11-20 21:28:34, 116.93 K

附件 7 : TRS937Annex4.pdf

2016-11-20 21:28:37, 265.93 K

附件 8 : TRS957Annex3.pdf

2016-11-20 21:28:39, 143.06 K

附件 9 : TRS961Annex4.pdf

2016-11-20 21:28:42, 315.38 K

附件 10 : TRS961Annex5.pdf

2016-11-20 21:28:46, 387.32 K

附件 11 : TRS961Annex6.pdf

2016-11-20 21:28:49, 167.23 K

附件 12 : TRS961Annex7.pdf

2016-11-20 21:28:51, 153.32 K

附件 13 : TRS970Annex2.pdf

2016-11-20 21:28:54, 321.56 K

附件 14 : TRS986annex2.pdf

2016-11-20 21:28:57, 279.1 K

附件 15 : TRS992_Annex3.pdf

2016-11-20 21:28:59, 198.06 K

附件 16 : TRS996_annex03.pdf

2016-11-20 21:29:02, 230.61 K

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引用回帖:

9楼: Originally posted by 1949stone at 2023-04-25 08:04:17
https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/distribution/trs957-annex5-who-good-distribution-practices-for-pharmaceutical-products.pdf...