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A CDMO Perspective Towards the Annex 1 Compliance |
Implementation of the new Annex 1 poses a challenge for the (bio)pharmaceuticals industry, especially for small size companies. This session will present an insight how a CDMO could approach the final Annex 1 guidance, evaluate the text, address internal shortcomings and opportunities for improvements in a gap analysis, and plan to bridge the gaps towards the compliance, including risk assessments and contamination control strategy.