Module 3 2019

Analytical QbD Elements

Definition of ATP Define characteristics of measurement system which will ensure accurate assessment of quality attributes over product lifecycle

Method Design Measurement technique selection and initial method development experiments to define knowledge space

Risk Assessment Identification of method parameters and assessment of their impact on method performance

Method Evaluation Assessment of experimental results and impact of method parameters on method performance. Define and verify Method Operable Design Region. Define and validate Normal Operating Conditions.

Definition of Method Control Strategy Establish critical method parameters. Define system suitability test to evaluate critical method attributes

Lifecycle Management Plan Define post approval management plan

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