New Drug Approvals

In May, the WHO published a draft guideline which describes the recommendations for ventilation systems used in the manufacture of non-sterile dosage forms. It also contains for the first time a definition for microbial requirements with regard to the zones E and F. Read more about the ventilation sytems recommendations.

http://www.gmp-compliance.org/enews_05367_WHO-defines-Requirements-on-Zones-E-and-F_15221,15231,15612,15266,Z-PEM_n.html

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…