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蠡怡良 2024-5-29 08:00

linger55 2024-3-8 09:38: 謝謝哥哥

椒陵小小兵 2023-11-8 13:32

tp206555 2023-9-23 07:18

521kaiyue 2023-6-27 14:31: asd2997610: GMP要求：专用生产设备且产品质量稳定的，可采用目检法确定可接受限度
我們合成後的産品是帶顔色的，然後我之前糾結是否應該做清潔驗證，因爲合成物特別容易凝固，會在設備內壁凝固一薄層淡淡顔色的固體，目視法應該是不行，不過還難溶水和絕大多數有機試劑，想溶解必須引入別的試劑，這樣會汙染反應釜，後來決定做風險分析報告，不做清潔驗證了！

521kaiyue 2023-6-27 14:18: 我們公司的合成溫度比較高，能到200多度，不會有交叉汙染的情況，合成過程不需要水和試劑，並且合成後作爲原料使用，都不在潔淨區內生産，需要驗證微生物嗎？

小金庫 2022-10-6 13:48

零下 2021-12-8 10:46: asd2997610: 美国变更分：重大变更，中等变更分30天生效的，还有0天生效的两类，还有就是年报的微小变更。个人感觉，对变更的评估无非是从影响药品的安全性，有效性，和质量 ...
謝謝大神

零下 2021-12-7 16:17: 你好，看您回複別人的帖子，關于美國的變更分類，能詳細介紹下麽？現在對于美國的哪些項目屬于次要，中等，重大的分類不是很明確

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