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蠡怡良 2025-9-2 09:00

准聖級藥老 2024-11-25 08:10: 徐龍: 谢谢大佬，在4.4.3 已经查阅到了，
“4.4.3 静态测试时，培养皿暴露时间为30min以上；動態测试时，培养皿暴露时间为不大于4h”.
再咨詢您一下。
1、動態的监测和 ...
還有就是對于覆蓋整個生産過程，好像並沒有哪個法規有明確的要求

准聖級藥老 2024-11-25 08:03: 徐龍: 谢谢大佬，在4.4.3 已经查阅到了，
“4.4.3 静态测试时，培养皿暴露时间为30min以上；動態测试时，培养皿暴露时间为不大于4h”.
再咨詢您一下。
1、動態的监测和 ...
是这样，静态定30min是因为沉降时间短，很难取到样。所以才会定30min。動態单个皿的暴露时间不大于4小时，也要看你们自己做的时间是多少，有可能2个小时培养皿就干了。如果说你動態生产过程不足半小时，我还是建议做30min以上。

准聖級藥老 2024-11-21 08:02: 徐龍: 您好。看你评论，说沉降菌需要做满半个小时（静态），这个是来源于什么指南文件吗？

PS：无菌原料药，B+A环境，由于批量小，分装全过程只有20min左右，这20min ...
應該是GB16294

Hnyy6csya 2024-11-19 10:10: 徐龍: 在无菌指南第14环境监测中有要求，但在开始制定时需要先进行相关评估，制定点位周期，在积累了一定数据后，可根据再评估降低相应点位或频率（但点位数量的要求需 ...
一起討論，互相學習。

Hnyy6csya 2024-11-19 10:09: 徐龍: 在无菌指南第14环境监测中有要求，但在开始制定时需要先进行相关评估，制定点位周期，在积累了一定数据后，可根据再评估降低相应点位或频率（但点位数量的要求需 ...
可以，個人理解是在沒有的基礎上制定都得基于風險評估、驗證等多方法確定相關的制定標准，在制定標准後可根據積累的數據在評估或驗證優化或完善原有的標准。

zhāng° 2024-3-18 16:54

貓咪特工 2022-7-24 09:07: 徐龍 : 注射液工艺验证3批产品需要全部包装吗？有没有相关法规参考？您有相关的法规参考吗？ GMP要求企业应当确定需要进行的确认或验证工作，以证明有关操作的关键要素能够得到有效控制。确认或验证的范围和程度应当经过风险评估来确定。如果经过风险评估，认为不外包装不会对产品或工艺产生影响，工艺验证批次不上市销售，此时可不进行完全包装。但是，应当注意，工艺验证批次往往需要进入稳定性考察计划，需要按市售包装形式或模拟包装形式（某些原料药）进行包装。 ...

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A JAPANESE AT HIS TOILET FOR A VISIT OF CEREMONY. A JAPANESE AT HIS TOILET FOR A VISIT OF CEREMONY. Top-side Galah! I prompted Camille to ask if he had ever encountered Ned Ferry, and he laughed. "But if she should be at Wiggins--" "And there is the whole trouble," I added. "She will not let you marry the woman whose--" A port crowded with steamers taking in coal, and very light barks high out of the water, kept in equilibrium by parallel outriggers at the ends of two flexible spars. These crank boats, made of[Pg 124] planks that scarcely overlap, were piled with luggage, and the boatmen jostle and turn and skim close under the fast-steaming transatlantic liners, amid a bewildering babel of shouts and oaths, under a sun hot enough to melt lead. 97 “You tell me who knew the way to get into the captain’s safe and I’ll try to get the emeralds.” The reporter interposed that it was the act of men maddened by grief and their losses. 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