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Setting Specification Acceptance Criteria under Consideration of Analytical Variability

Joachim Ermer and Hermann Wätzig describe a consensus paper developed by a working group of the German Pharmaceutical society

The ICH Guideline on specifications (ICH Q6A) establishes the principle that, provided safety and efficacy requirements are fulfilled, `a reasonable range of expected analytical and manufacturing variability should be considered'. Following extensive discussion, the Drug Quality Control/Pharmaceutical Analytics Working Group of the German Pharmaceutical Society (DPhG) has published a consensus paper with specific proposals on how to take analytical variability into account when establishing acceptance criteria for assays and for impurity determinations.

For drug product assays, it is recommended that acceptance limits should only be calculated in cases where analytical (or manufacturing) variability is outside the normal range, otherwise the (European) standard...

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