Review Article

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

Table 6

Role of analytical method in pharmaceutical testing and control strategy.

S. numberPharmaceutical testingControl strategy

1Raw material testingSpecification based on product QTPP and CQA
Effects of variability, including supplier variations, on process and method development are understood

2In-process testingReal time (at-, on-, or in-line) measurements
Active control of process to minimize product variation
Criteria based on multivariate process understanding

3Release testingQuality attributes predictable from process inputs (design space)
Specification is only part of the quality control strategy
Specification based on patient needs (quality, safety, efficacy, and performance)

4Stability testingPredictive models at release minimize stability failures
Specification set on desired product performance with time