Achieving a More Objective Assessment of Attribute and Parameter Criticality
Presented by Patrick Swann, Biogen Idec
The identification of Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) is a regulatory expectation. However, there are no uniform/harmonized approaches or criteria that can be used to distinguish “critical” from “non-critical” for either quality attributes or process parameters. Absent such criteria, the identification of CQAs and CPPs is susceptible to individual subjectivity and preference. This subjectivity can result in a lack of regulatory predictability, disharmony and puts at risk potential benefits of platform manufacturing. This presentation is intended to support a proposal that an explicit linkage between CQAs/CPPs and regulatory commitments (registered process description and control elements with associated regulatory lifecycle change management implications) can be leveraged to make the identification of criticality more objective and predictable.