5/6 July 2023
To cover the current regulatory and technological developments in the manufacture of sterile medicinal products, the EU Commission decided to revise the EU GMP Annex 1 "Manufacture of Sterile Medicinal Products". In particular, the integration of ICH Guidelines Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality System) as well as the inclusion of new technological developments made the revision of Annex 1 imperative.
After the launch more than five years ago, the EU Commission presented a first draft for public comment in 2017. More than 6.000 comments led, quite unusually, to a second draft for renewed public comment in 2020.
Long awaited, the final version of Annex 1 was now published on 25 August 2022. Below you can find the first information on deadlines and changes compared to the second draft version from 2020.
The basic structure of Annex 1 has remained unchanged.
Which changes / additions are obvious?
Further information can also be found in a complete comparison of documents.
One of the most important new requirements in the new Annex 1 is a Contamination Control Strategy. Learn more about this new requirement in the Live Online Training Contamination Control - Requirements, Measures and Strategy from 9-11 November.
Source: EudraLex- Volume 4 - Good Manufacturing Practice (GMP) guidelines Manufacture of Sterile Medicinal Products