认真解读国外GMP咨询方案,提升高标准药厂的设计能力

Study of GMP Consulting Scheme at Abroad and Enhancement in Design Ability of Standard Pharmaceutical Plant

针对新版GMP的即将推出,一些药厂向国外公司咨询符合欧盟标准的车间实施方案,笔者就一些例子指出不能盲目照搬这些方案,应根据具体的生产实际状况进行合理可行的项目设计。

In view of the fact that new version of GMP is coming, some Chinese pharmaceutical plants consulted from foreign companies for the execution schemes for the workshops which are consistent with EN standards. With some examples, it was pointed out in this article that these schemes could not to be directly employed, but the feasible project design should be carried out based on the practical production situation.