JVT

Intrinsic Compliance: A Model for Process Validation Optimisation

INTRINSIC COMPLIANCE This paper defines intrinsic compliance as a design technique applied to manufacturing systems and processes to ensure maximum alignment, connectivity and compatibility between process requirements and system capabilities across the 3-Stage PV Lifecycle. The technique is based on the identification of process:facility pairings and the sharing of risk-based datasets assigned at the point of process definition. Intrinsic compliance does not relate to GMP compliance in the procedural sense. SET THEORY Set theory, familiar from schooldays, is the primary basis of this paper. The...

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