ECA WHO对E、F区微生物限度进行规定

beiwei5du

ISO对于区域的划分是按照particle concentration的，没有规定相应的微生物限度（各国GMP中有对A,B,C,D级中微生物限度进行规定），WHO draft Supplementary Guideline on GMPs for Heating, Ventilation and Air-Conditioning Systems for non-sterile Dosage Forms在国际层面对相应的E,F区进行了相应的微生物相对规定。http://www.gmp-compliance.org/en ... -Zones-E-and-F.html

WHO defines Requirements on Zones E and F

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. 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.

wflyxm

学习了

胜利者

谢谢分享

syhorchid

学习一下

野性之吻

请问有没有原文 谢谢

beiwei5du

野性之吻 发表于 2016-6-13 09:06
请问有没有原文 谢谢

原文就在上面呢，这个是ECA的新闻