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Analytical Method Comparability Working Group

Analytical method comparability or equivalency assessments are generally required to ensure similarities when changes are made to analytical methods used in regulatory environment. Currently different approaches are utilized for these assessments in pharmaceutical industry, ranging from a simple comparison of precision and mean values between two methods, to a statistic-driven systematic evaluation study. The objectives of this working group are to formulate and propose common practice on analytical method comparability, and interact with regulatory authorities and compendia for possible guideline documents. A long-term goal would be to reduce regulatory filing burden on method change control, and to win supports from regulatory authorities on using analytical target profile (ATP) to replace specific analytical methods in regulatory submissions.

The working group purposely limited its initial scope to HPLC assay and impurity methods in registrational or post-approval stage, and is currently comprised of two sub-teams, i.e., scaled HPLC/UHPLC methods, different HPLC methods. Survey results have been received from ~ 20 companies in February 2013, and the working group is targeting to have two position papers in 3Q 2013.