欧盟GMP附录1《无菌产品生产》实施时间

bioreactor

Deadline for coming into operation:执行日期

- 25 August 2023 : one year from the date of publication in Eudralex Volume 4

- 2023年8月25日：欧洲药事法第四卷中发布后一年

- 25 August 2024 : two years from the date of publication in Eudralex Volume 4 for point 8.123

- 第8.123条款--2024年8月25日：欧洲药事法第四卷中发布后两年

8.123条款是特殊条款，要延迟到2024年8月25日生效，大家肯定很感兴趣具体的条款内容是什么？本条跟冻干机和相关产品转移、进箱和出箱有关，大家细品：

8.123 Lyophilizers and associated product transfer and loading/unloading areas should be designed to minimize operator intervention as far as possible. The frequency of lyophilizer sterilisation should be determined based on the design and risks related to system contamination during use. Lyophilizers that are manually loaded or unloaded with no barrier technology separation should be sterilised before each load. For lyophilizers loaded and unloaded by automated systems or protected by closed barrier systems, the frequency of sterilisation should be justified and documented as part of the CCS.

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小金库

对无菌制剂太不友好了