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
> Do not hesitate, we look forward to your feedback!
Write a comment on this news.