The EU’s eagerly anticipated revision of its good manufacturing practice (GMP) Annex 1 for sterile drug products was released on Thursday after 14 years of development. The revised requirements, which are set to take effect 25 August 2023, govern the manufacturing of sterile drugs made in the EU, as well as imported products.
The revised Annex comes after hints earlier this year that it be out in mid-2022. (RELATED: EU GMP Annex 1 revision to be released mid-year, Regulatory Focus 15 March 2022)
The existing Annex I has been in effect since 2008 and has undergone several proposed revisions since then. The latest proposed revision of the Annex was released for consultation in early 2020 and generated over 2,000 comments. (RELATED: EU begins second consultation to revise Annex 1 of EU GMP guide on sterile drug manufacturing, Regulatory Focus 6 March 2020)
The Annex has been revised to “reflect changes in regulatory and manufacturing environments. The new guideline should clarify how manufacturers can take advantage of new possibilities deriving from the application of an enhanced process understanding by using innovative tools as described in the ICH Q9 and Q 10 guidelines,” the Annex states…
