WTO.俄罗斯通报 G/TBT/N/RUS/101

 WTO.俄罗斯通报欧亚经济联盟良好制造规范规则修正案草案
编号：G/TBT/N/RUS/101
《欧亚经济联盟良好生产规范规则》修正案草案适用于在欧亚经济联盟境内流通的药品，并设想有必要对药品的鉴定和验证程序制定统一的办法，为了证明关键工序（设备）的参数满足规定的要求，以及当厂房、设备和工艺发生重大变化，可能影响成品质量时，从而使制药企业在一定质量水平上保证产品的稳定产出成为可能。

英文原文：
The Draft amendments to the Rules of the Good Manufacturing Practice in the Eurasian Economic Union applies to medicinal products put into circulation on the territory of the Eurasian Economic Union and envisages the need to establish a unified approach to the procedures for qualification and validation of medicinal products, in order to prove that the parameters of critical processes (equipment) meet the specified requirements, as well as in case of significant changes in premises, equipment and processes that may affect the quality of finished products, which makes it possible to ensure stable output of products with a given level of quality at pharmaceutical enterprises.(技术服务中心)