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Annex 1 has gone through multiple sets of industry review, comment, and revision. With the review and revisions, the application of quality risk management and risk principles has been identified as a foundational element for developing a robust contamination control strategy (CCS). Overall CCS goals include definition of critical control points, evaluation of control effectiveness, and technical/process knowledge – all factors which can be integrated into robust risk activities and through the use of practical risk assessment strategy. This presentation will evaluate the language used in Annex 1 to describe risk activities, where those activities are required, and explore risk assessment tools that will enable the contamination strategy goals.
