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Firms Look To Upgrade Aseptic Processing Lines As EU GMP Annex 1 Revision Takes Effect Globally

 
• By Bowman Cox

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.

Isolator
time to install rabs and isolators • Source: Shutterstock

A set of regulatory requirements to, among other things, upgrade sterile drug manufacturing facilities in ways that reduce the likelihood of workers contaminating products took effect 25 August in the European Union and in countries around the world whose pharmaceutical inspectorates have joined the Pharmaceutical Inspection Cooperation Scheme (PIC/S), as well as in the typically less-developed countries that adhere to World Health Organization GMP requirements.

Revisions to Annex 1 of the EU GMP guide and the nearly identical PIC/S and WHO Annex 1 documents establish...

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