Analytical Method Qualification and Validation: What and When?

As products move through development, the regulatory expectations for verification of the methods used to assess the product’s attributes change. Sample numbers and other variables in the verification program are subject to interpretation from ICH Q2(R1) Validation of Analytical Procedures: Text and Methodology. This presentation will describe appropriate levels of method qualification and validation needed during preclinical, phase I/II and phase III/market studies.


  • Niall Dinwoodie, MSc, BSc, Cchem, MRSC, Biologics Edinburgh Site Lead, Charles River