欧盟GMP中的留样数量

陶瑞鑫

做欧盟市场的老师，请问，制剂成品的留样，在国内要求是两倍量，但是不包括微生物项目。那对于欧盟市场，这个两倍量是不是需要加上无菌项目
The reference sample should be o f sufficient size to permit the carrying out, on, at least, two occasions, o f the fu ll
analytical controls on the batch in accordance with the Marketing Authorisation File which has been assessed and
approved by the relevant Competent Authority / Authorities. Where it is necessary to do so, unopened packs should
be used when carrying out each set o f analytical controls. Any proposed exception to this should be justified to，and
agreed w ith, the relevant competent authority.

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清晨的太阳

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xineia

如引用欧盟GMP内容所述很明确“at least, two occasions, o f the full analytical controls on the batch”，是至少全部检测项目的2倍量。还需要关注下Reference 和Retention Sample的区别；在文件规程中关注定义下区别。

桂圆和柚子

欧盟留样分为参考样品和留样，