EU GMP Annex 1 Explained: Sterile Manufacturing & Contamination Control - GxP Conversations Ep 25

EU GMP Annex 1 brings sterile manufacturing controls together, from cleanroom design and aseptic behaviour to monitoring and quality oversight. Episode 25 of GxP Conversations explores how those controls work as a system. Need support with your own facility or quality system? Ask about GMP consultancy. W2 Cleanroom Consulting: https://www.w2cleanrooms.com Kyle and Adam discuss the Contamination Control Strategy (CCS), quality risk management and the evidence needed to understand whether an operation remains under control. The conversation connects facility design, equipment, utilities, people and process decisions with day-to-day sterility assurance. Topics include: - Cleanroom qualification, first air and airflow visualisation. - Gowning, aseptic behaviour, isolators and RABS. - Terminal sterilisation, sterile filtration and aseptic processing. - Environmental monitoring, media fills, investigations and CAPA. We also explore why a sterility test cannot compensate for weak contamination prevention, and why the CCS needs to connect with actual practice. The revised Annex 1 was published in 2022 and became fully applicable on 25 August 2024. Confirm the relevant legal and local framework when applying its principles outside licensed sterile manufacture. #Annex1 #SterileManufacturing #ContaminationControl Use it free at: https://whatisgxp.com WinnPharma: https://winnpharma.co.uk Pharma QP: https://pharmaqp.co.uk EU GMP Annex 1: Manufacture of Sterile Medicinal Products https://health.ec.europa.eu/document/download/e05af55b-38e9-42bf-8495-194bbf0b9262_en?filename=20220825_gmp-an1_en_0.pdf EudraLex Volume 4 https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en MHRA GMP and GDP guidance https://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practice ICH Q9(R1): Quality Risk Management https://database.ich.org/sites/default/files/ICH_Q9(R1)_Guideline_Step4_2025_0115.pdf EU GMP Chapter 1: Pharmaceutical Quality System https://health.ec.europa.eu/document/download/e458c423-f564-4171-b344-030a461c567f_en?filename=vol4-chap1_2013-01_en.pdf Help Me GxP is co-created and run by Kyle Winn and Adam Walker, who are also directors of W2 Cleanroom Consulting. W2 sponsors the channel. This video is for education. Use it alongside current guidance, your approved procedures and formal training.