Analytical procedures lifecycle management: An overview

Abstract

The concept of QbD that has already given positive results, can be applied to the analytical methods as well. АQbD approach is based on ICH Q8, Pharmaceutical development; ICH Q9, Quality risk management and ICH Q10, Pharmaceutical quality system, with the same steps as in the technological process of QbD, including: definition of the аnalytical target profile, ATP; critical quality attributes of the methods, CQAs; risk assessment; method оperable design region, MODR; control strategy and lifecycle management. By applying the design of the experiments, DoE, which is used to determine the link between the factors that influence the method's performance and the results obtained, one acquires information for the influence of more variables. The whole process of applying of АQbD should be based on solid scientific evidence. The application of AQbD shall strengthen the concept “right analytics at right time”. In this approach, the robust methods are being developed, the analytical method can be applied in the framework of the defined MODR, the number of out of specification (OOS) and out of trend (OOT) results is being reduced and regulatory flexibility is enabled.