20140903 ECA新闻：欧盟发布期待已久的EU GMP指南第3章和第5章（Julia翻译）

巴西木

GMP News
03/09/2014

EU Commission publishes long-awaited EU GMP Guide Chapters 3 and 5

欧盟发布EU GMP指南第3章和第5章

The EU Commission had published its first draft of the chapter 3 "Premises and Equipment" and 5 "Production" for comments in early 2013 (see news from 04/12/2013). The content concerns the measures for avoiding cross-contamination and the regulation relative to which products have to be produced in dedicated facilities.

欧盟委员会在2013年很早时就公布了第3章“设施和设备”及第5章“生产”的第一版本草稿（参见2013年4月12日新闻）。内容包括避免交叉污染的措施和必须在专用设施中生产的产品规定。

The mention of specific products for which a dedication is required - as provided in the currently valid version of chapter 3 - is missing in the now published version. The quality risk management approach is maintained. Also remaining are the exceptions where dedication is required - which are:

现行版本第3章中关于需要专用设施的特定产品在新公布的版本中没有了。质量风险管理方法留在文中。同时保留的还有需要专用设施的例外情况，如下：

• The risk cannot be adequately controlled by operational and/ or technical measures, or
• 风险不能由操作和/或技术措施充分控制，或
• Scientific data from the toxicological evaluation does not support a controllable risk (e.g. allergenic potential from highly sensitising materials such as beta lactams) [Note: the draft version was mentioning missing thresholds], or
• 毒理学评估的科学数据不支持可控风险（例如，高致敏物料如?内酰胺的致敏可能性）【注：草案中提到没有阈值】，或
• Relevant residue limits, derived from the toxicological evaluation, cannot be satisfactorily determined by a validated analytical method.
• 毒理学评估中获得的对应的残留限度不能由经过验证的分析方法来测定获得满意结果
  

But the main difference to last year's draft version is that there is no referencing for how the repeatedly mentioned toxicological assessment has to be done. The last draft for this purpose referenced the EMA Guideline (setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities), which is still in draft stage and is subject of controversial discussions. This of course creates new liberties. At the same time, though, it generates just as much uncertainty what such a toxicological assessment has to look like after all to be accepted by the authority. Chapter 5.20 provides some indications with regard to how the decision process has to be done risk-based and scientifically formal. Concrete information on the toxicological risk classification or derivation of the limit cannot be found here.

与去年的草稿主要的不同之处在于新版没有对于反复提到的毒理评估必须如何去做的引用。 该引用文献最后的草稿是EMA指南，该指南仍在起草阶段，其内容被广泛争论中。这样理所当然创造了新的自由度。同时，尽管这样的毒理评估会是什么样目前还完全不确定，不管怎么它将要被药监当局所接受。第5.20节提供了一些关于如何基于风险和科学方式做出决策。在这里找不到关于毒理风险分类和限度制订的具体信息。

To find the new Chapters valid from 1 March 2015 please see

2015年3月1日开始生效的新章节参见

• Chapter 3 "Premises and Equipment"
• 第3章 设施与设备
• Chapter 5 "Production"
• 第5章 生产
  

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巴西木的更新总是很合乎我这个菜鸟的胃口啊{:soso_e113:}