EDQM通知：CEP物质关于工艺用水的问题

julia朱玉姣

英文原文来自EDQM官网 http://www.edqm.eu/en/edqm-homepage-628.html

02 September 2015

2015年9月2日

Reminder for applicants –water mentioned on a CEP

申请人需知---CEP将载明最终步骤工艺用水

The EDQMwould like to remind holders of certificates of suitability (CEP) and theircustomers about the policy to be applied when water is used in themanufacturing process of a pharmaceutical substance.

在此EDQM提醒CEP持有人及其客户关于药用物质生产工艺用水所适用的原则。

Whenwater is used in the final steps of the manufacture of a substance, this ismentioned on the CEP. By default the required quality is potable water asdefined in the CPMP/CVMP Note for Guidance on quality of water forpharmaceutical use (CPMP/QWP/158/01 Revision & EMEA/CVMP/115/01 Revision).

如果在物质生产最终步骤使用了水，则在CEP上要载明。默认水质要求是饮用水，质量要求满足CPMP/CVMP通知“工艺用水质量指南”的要求（CPMP/QWP/158/01修订版&EMEA/CVMP/115/01修订版）。

Users arereminded that the Certification procedure does not consider the finaluse of a substance. Assessment is performed taking into account the generaluse, although in some cases further requirements with regards the quality ofwater are applicable, depending on the intended use of the active substance,which need to be considered in the context of the evaluation of the marketing authorisationapplication (MAA) for the finished medicinal product.

提醒用户的是，认证程序并未考虑物质的最终用途。尽管有时候也会根据活性物质既定用途不同对水质有进一步要求，但评估时考虑的只是常规用途，而在制剂成品的上市许可申报（MAA）评估中则需要考虑这些问题。

Only inspecial situations where the CEP holder claims the grade “sterile” for anactive substance or the grade “to be used in parenteral preparations” (andprovided it is foreseen by the Ph. Eur monograph), the quality of water will beassessed accordingly and declared on the CEP.

只有在特殊情形下，即CEP持有人声明活性物质为“无菌”级别，或其级别“将要用于注射剂生产”时（假定这是EP各论里已预见的），水的质量才会被做相应评估，并在CEP里声明。

Therefore,for an active substance which is not sterile but is intended to be used in asterile medicinal product, and when water is mentioned on the CEP, suitableevidence should be submitted in the MAA to confirm compliance of the water withthe corresponding requirements. CEP holders should therefore provide thenecessary data to their customers, for inclusion in the concerned MAA orvariations.

因此，对于非无菌活性物质，但要用于无菌制剂生产，且CEP中载明工艺用水时，在MAA中应提交适当的证据以确认水质符合相应的要求。CEP持有人应提供必要的数据给其客户，让其包括在相关的MAA或变更里。

北重楼

这个国外要求越来越狠了