The 2011 FDA Process Validation Guidance describes process validation activities in three stages. Stage 1 is design of the commercial process, Stage 2 is process performance qualification, and Stage 3 is continued process verification. The emphasis of this guidance document is on design, lifecycle and control of variability. As a component of process validation for API manufacture, it is recognized worldwide that limits must be established for the reuse of chromatography resins in commercial manufacturing processes.  This talk will illustrate how validation activities to support resin lifetime limits span all three stages of the process validation lifecycle.  The design of studies performed during the process design stage will be discussed.  These studies are used to pre-establish reuse conditional limits based on criteria that address both product quality and process performance.  Next, the process of selecting attributes and criteria that are most appropriate for monitoring and evaluating chromatography resins during commercial manufacture (PPQ and subsequently CPV) will be discussed.

Designing resin end of lifetime studies and their application in the three stages of process validation

251st National Meeting (2016)

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