EU GMP与PIC/S PI009有什么区别

蓝色星期六

如题,EU GMP与PIC/S PI009有什么区别?附录几乎是一样的,EU GMP 是2005年版本,PI009是2014年版.谁抄袭谁呢?还是一个团队起草的?

shsh

pic/s009开始不就是说了和EU GMP的关系
In 1989, the EU adopted its own GMP Guide, which – in terms of GMP requirements – was equivalent to the PIC/S GMP Guide. Since that time, the EU and the PIC/S GMP Guides have been developed in parallel and whenever a change has been made to one, the other has been amended so that both Guides are practically
区别也说了几点
are, however, some differences between the two Guides. These differences are the following:
? the definition of Pharmaceutical Product (referred to as “Medicinal Product” in this Guide), which is found in Article 1 of the Pharmaceutical Inspection Convention, has been retained;
? references to the EU Directives, as well as to MRAs, have been deleted;
? the expression “authorised person” (see Glossary) is used in the PIC/S Guide while the expression “Qualified Person” is used in the EU Guide;
? since not all Participating Authorities under the PIC Scheme are parties to the European Pharmacopoeia Convention, the mention of “European Pharmacopoeia” in the Guide has been amended to read “European or other relevant Pharmacopoeia”.
有什么问题么?这两个GMP一致的,附录中不一样的地方用星号做了说明

十二月的雪

学习下！~~~~~~

蓝色星期六

pic/s009开始不就是说了和EU GMP的关系
In 1989, the EU adopted its own GMP Guide, which – in terms o ...[/quote]
每仔细研读PICSPI009，呵呵。谢谢指点

beiwei5du

请问WHO GMP和PIC/s GMP有多大区别呢？谢谢！

beiwei5du

像澳大利亚参加PIC/s，其TGA GMP和PIC/s GMP有多大区别呢？谢谢

一墨

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