Module 9 2021

19/03/2021

Different Approaches Exist to Identifying CQAs

• Consider all DP quality attributes; physical attributes, identification, assay, degradation products, microbial limits, etc. • Identify a CQA based on the severity of harm to a patient (safety and efficacy) resulting from failure to meet that quality attribute.

 Identified before taking into account risk control  Does not change as a result of risk management

The Organisation for Professionals in Regulatory Affairs

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CQA Assessment

1. What is the potential impact to patients when high or low levels of a variant are present Impact : 2-20 points Four impact aspects to consider Biological activity, Immunogenicity, PK and Safety 2. How certain are we about question 1? Uncertainty: 1-7 points Combine as a Risk Ranking and Filtering Assessment Useful tools; Risk assessments, prior knowledge and established science.

The Organisation for Professionals in Regulatory Affairs

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