Annex 1 is finally out! Finally the new Annex 1 is published, after 7 years. The challenge is how best to apply good science and GEP (good engineering practice), as the goal is to improve product quality and ultimately patient safety and wellbeing. The deadline for coming into operation of Annex 1 for both EMA and PIC/s documents is 25 August 2023, except for clause 8.123 which is postponed until 25 August 2024. New Annex 1 has 59 (58) pages Vs 16 in 2008 version The assessment of risks (hazards) across the entire manufacturing process (QRM), and having a coherent and comprehensive contamination control strategy (CCS) in in the new Annex 1 has been a core element of Ardmac’s best practice GMP cleanroom design and applications. For decades Ardmac’s engineers have been driven by the need for a detailed understanding of the process and hazards involved and the impact of contamination sources on client’s processes. The new Annex 1 is a culmination of a review and consultation process that started in 2015. The new EU-GMP Annex 1 is designed to encourage the use of new technologies in sterile manufacturing, the increased use of isolators and RABS designs as well as incorporating the changes in ISO Cleanroom Standards (ISO 14644 series of dashes).
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