What changed in the 2022 revision: the Contamination Control Strategy requirement, barrier technology expectations, and integrated QRM.
This course covers what changed in the 2022 revision of EU GMP Annex 1 compared to the prior version, the Contamination Control Strategy requirement introduced under Section 4, barrier technology expectations for aseptic processing including isolators and RABS, and the environmental and personnel monitoring requirements the revised Annex sets out.
The 2022 revision is the most significant change to EU sterile manufacturing regulation in over a decade, and its reach extends well beyond the EU since many non-EU sites reference it for their own sterile programs. Facilities that have not updated their CCS and monitoring programs to match are increasingly exposed at inspection.
Completion certificate, PDF slide download, and access to the complete GMP course library from day one.
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