Correction: This article was edited on 15 September 2022 to correct Jorg Zimmermann's title. Sterile drug manufacturers should start preparing a gap analysis to identify what needs to be done to ...

Aseptic gowning procedures play an important role in supporting contamination control strategies across pharmaceutical and ...

One of the main goals of pharmaceutical regulatory rules is to keep environmental contamination at a minimum. According to the EU GMP Annex 1 regulatory standard for sterile drug products, a ...

Regulatory pressure is another catalyst. The revised EU GMP Annex 1, which took effect in recent years, introduced stricter requirements around contamination control strategies, pushing drugmakers to ...