After 14 years of development, the long-awaited revision of EU’s good manufacturing practice (GMP) Annex 1 for sterile drug products was released on 25 August 2022. The revised requirements, which are set to take effect on 25 August 2023, govern the manufacturing of sterile drugs made in the EU, as well as imported products.
The Annex has been revised to “reflect changes in regulatory and manufacturing environments”.
There is a new section on the pharmaceutical quality systems, which incorporates the principles of quality risk management (QRM) (ICH Q9) and pharmaceutical quality systems (ICH Q10) into sterile drug manufacturing.
The revision harmonizes sterile drug manufacturing principles with those of the World Health Organization (WHO) and Pharmaceutical Inspection Cooperation Scheme (PIC/S) standards of sterile drug manufacturing, as well as better align with the US Food and Drug Administration’s (FDA) 2004 guidance on sterile drug products manufactured by aseptic processing.
The Annex will take effect on 25 August 2023, except for section 8.123 on lyophilizer sterilization, which takes effect one year later 25 August 2024.
2 Bridge’s CMC & quality team are experts in the EU regulatory GMP framework and we look forward to working with our GMP C(D)MOs to implement this new GMP annex within our ongoing and future projects.