The Challenges of Achieving Clinically Relevant CM&C Specifications
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*Jeffrey D Hofer, Eli Lilly and Company 

Keywords: specifications, acceptance criteria, bioequivalence

The linkage of acceptance criteria to clinical relevance is a key facet in the new risk-based initiative. While it is easy to express a desire to establish such a linkage, it is nevertheless quite challenging to actually do so. Recently, the importance of the clinical relevance of acceptance criteria used in relationship to risk assessments has become more recognized. Some of the technical and pragmatic challenges of achieving CM&C specifications directly linked to product fitness for use will be discussed related to bioequivalence requirements and clinical dose response curves. This talk will highlight the fact that the current interpretation of acceptance criteria, which focuses on individual test results, is not consistent with a clinically relevant framework as opposed to an alternative interpretation of acceptance criteria as referring to batch parameters.