News about GMP/cGMP


Update on Publication Date of EU Annex 1 at the ISPE Conference.

Update on Publication Date of EU Annex 1 at the ISPE Conference.

On 14/15 March 2022, the ISPE Aseptic Conference took place in North Bethesda, USA. The hybrid conference opened with a keynote presentations on regulatory news.

Paul A. Gustafson, who is chairing the PIC/S this year, gave an overview on the PIC/S activities and in this context referred to the future Annex 1 of the EU GMP Guide: The document is in its final adoption process. A publication is to be expected between the beginning of July and the end of September this year. The European Commission is currently awaiting the review of the PIC/S and the WHO. Both organisations had contributed to the two draft documents of Annex 1. The European Commission has not revealed a release date, yet.

Gustafson stated that the new Annex on sterile manufacturing of medicinal products will have a significant impact on aseptic and sterile manufacturing. He mentioned, e. g., that the working group has adjusted the requirements for freeze dryers based on the comments received, or that exemptions for radiopharmaceuticals have also been made.

After publication, a one-year transition period is foreseen before Annex 1 will enter into force. For the section on lyophilisers, two years will be granted. This should allow sufficient time for training and implementation. Furthermore, the aspect of harmonisation will remain in focus. An Aide Memoire might be published for this purpose.


RAPS: EU GMP Annex 1 revision