Q2(R2) Validation of Analytical Procedures

On 26 August 2022 the FDA published draft guidance on ICH Q2(R2).

This guideline presents a discussion of elements for consideration during the validation of analytical procedures included as part of registration applications submitted within the ICH member regulatory authorities. Q2(R2) provides guidance and recommendations on how to derive and evaluate the various validation tests for each analytical procedure. This guideline serves as a collection of terms, and their definitions. These terms and definitions are meant to bridge the differences that often exist between various compendia and documents of the ICH member regulatory agencies.

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