Firms Look To Upgrade Aseptic Processing Lines As EU GMP Annex 1 Revision Takes Effect Globally
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.
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Important updates to good manufacturing practice guidelines are likely to mean medicine shortages, warns a German pharmaceutical industry group.
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.
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.