Firms Look To Upgrade Aseptic Processing Lines As EU GMP Annex 1 Revision Takes Effect Globally
Executive Summary
Sterile drug manufacturers get one year to comply with most revisions in updated EU, PIC/S and WHO GMP Annex 1 guideline. PDA survey hints at scale of challenge facing firms that still use traditional open filling lines, a practice expected to end under the Annex 1 revisions.