Do we need to validate analytical methods when we replace old instruments by new instruments?
ICH Q2R2 chapter 2.2 offers three scenarios that depend on the degree of performance differences between the two instruments. In case the readout is comparable (working under GMP with plan and report, defining comparability acceptance criteria a priori in the plan), no re-validation but instead a science-based update would be a preferred way to go. In case minor differences (such as a well-defined offset in a measured value) occur, a partial re-validation could be the way to go (e.g. defining the offset and new setting of affected new SST criteria or specification limits). In case comparability cannot be confirmed, a full revalidation would be necessary. We describe this procedure also in https://doi.org/10.1002/elps.70004 , especially check out figure 2 and chapter 4.1.
Join Dr. Anne Ries from Boehringer Ingelheim Pharma to explore Universal Study Design for Instrument Changes in Pharmaceutical Release Analytics.
Watch the On-Demand presentation now: https://bio-qc.com/best-practices-for-updating-analytical-procedures-in-drug-development-and-manufacturing/
Plus, don’t miss her expert insights during the panel discussion on Best Practices for Updating Analytical Procedures in Drug Development and Manufacturing.
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