10/11 March 2020
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.