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

Table 3

Implementation of analytical QbD in pharmaceutical quality system.

S. number	Implementation stagewise	Description
1	Target measurement	Determine what to measure and where/when to measure it. Define ATP and develop measurement requirements based on product QTPP and CQA.
2	Select technique	Select appropriate analytical technique for desired measurement defined in ATP. Define method performance criteria.
3	Risk assessment	Assess risks associated with method input variables, sample variation, and environmental conditions. Risk assessment tools (e.g., FMEA) can be used.
4	Method development and validation	Examine potential multivariate interactions by DoE and define MODR to understand method robustness and ruggedness.
5	Control strategy	Define control space and system suitability; meet method performance criteria to meet ATP.
6	Continual improvement	Monitor method performance that remains compliant with ATP criteria and thus analysts proactively identify and address the out-of-trend performance of the method. Update with new process and analytical technology.