Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics

Table 1

Regulatory perspective; product QbD versus analytical QbD.

Stage	Product QbD	Analytical QbD
Stage 1	Define quality target product profile (QTPP)	Define analytical target profile (ATP)
Stage 2	Critical quality attributes	Critical quality attributes
Stage 3	Risk assessment	Risk assessment
Stage 4	Design space	Method operable design region
Stage 5	Control strategy	Control strategy
Stage 6	Life cycle management	Life cycle management