Module 3 - Strategic case studies in practice

Approach to Identify CQAs 1. Consider all DP quality attributes; physical attributes, identification, assay, content uniformity, dissolution and drug release, degradation products, residual solvents, moisture, microbial limits, etc. 2. 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

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