The revision of EU GMP Annex 1, Manufacture of Sterile Medicinal Products was finalized in August of 2022 by the European Commission. The final draft has expanded the annex from 16 to over 50 pages and includes new requirements as well as additional detail related to many of the requirements presented in the previous version of Annex 1 from 2008.
2008 EU GMP Annex 1
PDA has been and continues to be very involved in this topic. Below are materials produced by a dedicated team of PDA volunteers and submitted to the EMA during the revision process. These items provide a historical context for PDA's activity as well as the broader industry perspective and involvement to ensure that the final version of Annex 1 reflected concerns and practical considerations expressed by the pharmaceutical manufacturing community.
PDA Commenting Team on the EU GMP Annex 1 Revision
In July of the 2020, PDA submitted comments to the EMA on the Annex 1 draft (version 12). The comments were developed by an active PDA Commenting Team comprised of experts in the field of aseptic processing.
EU GMP Annex 1 Revision Draft (version 12)
Cross-Association Coordination Group on EU GMP Annex 1 Revision
PDA is also part of a Cross-Association Coordination Group which includes A3P, AnimalhealthEurope, AESGP, ECA, EFPIA, EIPG, EQPA, ISPE, Medicines for Europe, PDA, PHSS, and Vaccines Europe. This group meets to discuss the Annex 1 revision and has developed Joint letters on areas where there is shared positions amongst all the associations. Two letters have been developed to date.
Implementation Examples - EU GMP Annex 1 Draft (version 12) - 25 May 2021