Recent revisions to EU manufacturing guidelines are changing how drug makers test processing technologies, according to the author of a new study, who cites growing use of an approach known as PUPSIT ...

Pharmaceutical manufacturers in the EU may have to approach the manufacturing of sterile drugs a little differently under the EU’s Annex 1 covering good manufacturing practices (GMPs), which goes into ...

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 ...