欧盟GMP又修订三章

1009889281

欧盟GMP第三章 Premise and Equipment,第五章 Production，第八章Complaint and recall 2015年3月起实施

第三章改动不大

第五章修订原因：Reasons for changes: Changes have been made to sections 17 to 21, including adding a new section, to improve the guidance on prevention of cross-contamination and to refer to toxicological assessment. Changes were also introduced in sections 27 to 30, including adding a new section, on the qualification of suppliers in order to reflect the legal obligation of manufacturing authorisation holders to ensure that active substances are produced in accordance with GMP. The changes include supply chain traceability. Sections 35 and 36 are inserted to clarify and harmonise expectations of manufacturers regarding the testing of starting materials while section 71 introduces guidance on notification of restrictions in supply.

第八章修订原因：Reasons for changes: Extensive changes have been made to this Chapter which now reflect that Quality Risk Management principles should be applied when investigating quality defects or complaints and when making decisions in relation to product recalls or other risk-mitigating actions. It emphasises the need for the cause(s) of quality defects or complaints to be investigated and determined, and that appropriate preventative actions are put in place to guard against a recurrence of the issue and clarifies expectations and responsibilities in relation to the reporting of quality defects to the Competent Authorities.

幻影

julia已经翻译了。

夜下独行

全英文的  看不懂呀

幻影

@tang_yanjin 巴西木都发帖了吧。

秋天的风

xx................

syhorchid

谢谢分享

曾江波

有翻译啊  

是是而非

翻译在哪呀

一沙一叶

论坛里面有，搜一下

一沙一叶

是是而非 发表于 2014-9-5 18:17
翻译在哪呀

论坛里面有，搜一下

唐延进

幻影 发表于 2014-9-5 16:28
@tang_yanjin 巴西木都发帖了吧。

链接能给一个吗

唐延进

幻影 发表于 2014-9-5 16:28
@tang_yanjin 巴西木都发帖了吧。

链接能给一个吗