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.
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 new Annex 1 will come into force on 25 August 2023, i.e. exactly one year after publication in Eudralex Volume 4.
Only with regard to Chapter 8.123 "Product transfer / loading/unloading areas for lyophilizers" the deadline is two years, i. e. until 25 August 2024
Changes compared to the second draft version of 2020
The basic structure of Annex 1 has remained unchanged.
Pharmaceutical Quality System (PQS)
Production and specific technologies
Environmental and Process monitoring - instead of Viable and non-viable environmental and process monitoring
Quality control (QC)
Which changes / additions are obvious?
Annex 1 has become more comprehensive. The number of pages has increased from 52 to 58.
The subchapter "Barrier Technologies" in the chapter "Premises" has almost doubled. The topics of background environment, gloves and decontamination methods have been dealt with separately for Isolators and RABS.
The subchapters "Form-Fill-Seal (FFS)" and "Blow-Fill-Seal" in the chapter "Production and Specific Technologies" have almost tripled in scope and go into much more detail.
In addition, there are further deletions, summaries and new insertions in many chapters, as well as rewordings, which will be dealt with in the following news.