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Timeline For EU GMP Annex 1 Revision Remains Unclear

 
• By Joanne S. Eglovitch

Annex 1 update: A pharmaceutical industry insider says that while Brexit has slowed the work of EMA guidance development, exceptions are Annex 1 and Annex 21, which are deemed high priority.  Word has it that the controversial PUPSIT requirement has been included in the latest draft, and that the annex's next rapporteur will come from the French national competent authority.

Bosch: Capping machine with highly an isolator is a hermetically sealed system with a complete separation of operator and process area © Bosch Packaging Technology

Despite the European Medicines Agency according GMP Annex 1 a high priority work item, it is still unclear when a revised annex will be released and whether a final version will be implemented right away or go out again for public comment.

So asserted Jean-Francois Duliere, a GMP consultant who is chair of the International Society for Pharmaceutical Engineering's France affiliate, and...

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