Validation of test methods needed to the control critical quality attributes of biological drug products can present unique challenges. Often validation approaches can be limited by the quantity, availability, or characteristics of materials available for use in executing validation plans. With regards to the validation of quantitative impurity methods, it is typical that isolated and characterized impurities are unavailable at the time of method validation, precluding a direct assessment of method accuracy. ICH Q2(R2) “Validation of Analytical Procedures" provides that " In certain cases, accuracy can be inferred once precision, response within the range, and specificity have been established”, presumably in anticipation that a direct assessment of method Accuracy may not always be possible. This presentation will discuss strategies for inferring method Accuracy, for quantitative impurity methods, via a rigorous demonstration of method precision, range, and specificity.
Learning Objectives:
Upon completion, the participant will be able to implement strategies for validating quantitative impurity methods that infer method Accuracy, through the establishment of precision, range, and specificity.
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