Journal of Chemistry / 2015 / Article / Tab 1

Review Article

Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing

Table 1

QbD tools for synthetic development and analytical development.

StepsSynthetic development (QbD)Analytical development (AQbD)

1QTPP identificationATP (Analytical Target Profile) identification
2CQA/CMA identification, Risk AssessmentCQA identification, Initial Risk Assessment
3Define product design spaceMethod Optimization and development with DOE
Define process design space
4Refine product design spaceMODR (Method Operable Design Region)
5Control Strategy with Risk AssessmentControl Strategy with Risk assessment
6Process validationAQbD Method Validation
7Continuous process monitoringContinuous Method Monitoring