The current Annex 1 "Manufacture of sterile medicinal products" of the EU GMP guidelines contains both familiar requirements and new topics. Cleanroom garments must also be considered against the background of the Contamination Control Strategy (CCS).
This GMP:talk will focus in particular on the points that are currently being discussed during inspections, e.g. how can the pharmaceutical manufacturer prove why and when garments are replaced?
The audience can participate in the discussion and ask questions.
Interview partners: Carsten Moschner, CMC3 - expert for cleanroom clothing; Thomas Peither, GMP expert & journalist
The current Annex 1 "Manufacture of Sterile Medicinal Products" of the EU GMP Guide contains both familiar requirements and new topics. Cleanroom garments must also be considered against the background of the Contamination Control Strategy (CCS).
This GMP:talk will focus in particular on the points that are currently being discussed during inspections, e.g. how can the pharmaceutical manufacturer prove why and when garments are replaced?
The audience can take part in the discussion and ask questions.
