欧盟发布期待已久的EU GMP指南第3章和第5章
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欧盟发布期待已久的EU GMP指南第3章和第5章
笔记 2014-09-05 ECA 欧盟委员会于2013年初公布第3章“厂房与设备”和第5章“生产”第一版草案征询意见。内容包括交叉污染的避免措施和专用设施中生产产品的监管措施。 现行版第3章规定的需要专用设施的特殊产品在新版本中已删去。质量风险管理路径保留。同时保留的还有需要专用设施的例外情况，如下：
与去年草案版本的主要不同之处在于新版指南没有引用反复提到的毒理学评估应如何去做。上一版草案中出于该目的引用了EMA指南（共用设施中不同药品生产风险识别所用基于健康的暴露限设定指南），这一指南仍在起草阶段且处于广泛争议中。这理所当然给出了新的自由度。与此同时，虽然总将被监管机构接受，但对于这样的毒理学评估应该是什么样会有很多不确定因素。第5.20章节为如何基于风险和科学方式作出决策做提供了一些指示。有关毒理学风险分级或限度来源的有效信息无法在这里找到。 2015年3月1日将开始生效的新章节请见 编译：识林-椒 2014-09-05 EU Commission publishes long-awaited EU GMP Guide Chapters 3 and 5 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. 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: The risk cannot be adequately controlled by operational and/ or technical measures, or 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 Relevant residue limits, derived from the toxicological evaluation, cannot be satisfactorily determined by a validated analytical method. 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. To find the new Chapters valid from 1 March 2015 please see 原文请见 EU Commission publishes long-awaited EU GMP Guide Chapters 3 and 5 |