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. number
Pharmaceutical testing
Control strategy
1
Raw material testing
Specification based on product QTPP and CQA Effects of variability, including supplier variations, on process and method development are understood
2
In-process testing
Real time (at-, on-, or in-line) measurements Active control of process to minimize product variation Criteria based on multivariate process understanding
3
Release testing
Quality 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)
4
Stability testing
Predictive models at release minimize stability failures Specification set on desired product performance with time