Final Revisions Should Ease Global Use Of EU GMP Annex I Sterile Drugs Guidance, Associations Say

 
• By Joanne S. Eglovitch

Inter-associations working group suggests changes to the EU GMP Annex I revision to make it easier to understand by health authorities worldwide; the groups point out that the annex will be used globally and not just in Europe.

Bosch: Capping machine with highly an isolator is a hermetically sealed system with a complete separation of operator and process area © Bosch Packaging Technology
Annex I Needs Clearer Distinctions Between RABs And Isolators • Source: Shutterstock

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