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.
You may also be interested in...
Companies Need EU Funding To Cover ‘Enormous Expenditure’ Of Complying With Revised GMP Rules
Important updates to good manufacturing practice guidelines are likely to mean medicine shortages, warns a German pharmaceutical industry group.
Sterile Drug GMPs: CCS Tool Could Help Bridge Compliance Gaps As Annex 1 Revisions Take Effect
Experts who led PDA’s interactions with EU, PIC/S and WHO authorities on first-ever comprehensive revision of sterile drug product manufacturing guidance recently shared insights on implementation priorities with the Pink Sheet.
EMA, PIC/S to Revise Annex 1 Sterile Manufacturing Guidelines; PDA Offers Detailed Advice
International authorities and global manufacturers are embracing the opportunity for a more scientific, risk-based approach to sterile manufacturing. The hard part will be agreeing on just what that is.