[ECA新闻]WHO定义了E和F级洁净区的要求

WHO定义了E和F级洁净区的要求

In May 2016, the WHO published a draft guideline which describes the recommendations for ventilation systems used in the manufacture of non-sterile dosage forms. From a technical point of view, the guideline is very interesting and includes a detail which may be overlooked: it contains - as first international GMP guideline - a proposal for the definition of microbiological requirements
concerning the zones E and F. So far, the approach to extend the zoning via the zones A-D defined in Annex 1 to the zones E and F and thus define microbial limits had only been available in an Aide Memoire of the ZLG (in German language). Now for the first time, this information is available in an international guide. As there are far less regulations in the area of non-sterile medicinal products than in sterile manufacturing, the proposal should be of great interest.

在2016年5月，WHO公布了一份指南草案，其中描述了用于非无菌制剂生产的通风系统的建议。从技术角度来说，该指南非常有意思，它包括了一些可能会被忽视的细节—作为首个国际GMP指南---关于E和F地带微生物的要求定义。到目前为止，这份草案附录1中所定义的将洁净级别从A-D延伸到E和F级，并定义其微生物限度就只在德国ZLG备忘里有（德语）。现在，该信息首次出现在一份国际指南中。由于在无菌生产中的法规远少于非无菌药品领域，此建议是非常有益的。

Access the draft Supplementary Guideline on GMPs for Heating, Ventilation and Air-Conditioning Systems for non-sterile Dosage Forms on the WHO webpage to find more detailed information. The deadline for comments ends on
12 July 2016.

此指南草案在WHO官网上可以下载。征求意见截止日期为2016年7月12日。