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.

Steps	Synthetic development (QbD)	Analytical development (AQbD)
1	QTPP identification	ATP (Analytical Target Profile) identification
2	CQA/CMA identification, Risk Assessment	CQA identification, Initial Risk Assessment
3	Define product design space	Method Optimization and development with DOE
	Define process design space
4	Refine product design space	MODR (Method Operable Design Region)
5	Control Strategy with Risk Assessment	Control Strategy with Risk assessment
6	Process validation	AQbD Method Validation
7	Continuous process monitoring	Continuous Method Monitoring