The MHRA recently started a consultation on the application of Analytical Quality by Design (AQbD) to pharmacopoeial standards. The comment period will end this month on 31 August 2019. In order to encourage stakeholders to take the opportunity to send comments on the proposed approach, the MHRA provides the following questions together with answers given by two pharmacopoeial scientists for the British Pharmacopoeia (BP):
Why is the MHRA interested in AQbD for Pharmacopoeial Standards? In UK, the BP sets the legal standards by which UK pharmaceuticals are analyzed. It is therefore critical that the methods used are suitable for all products throughout their lifecycle and that the results they produce are accurate. "AQbD has the potential to aid these decisions through the application of the principles detailed in the technical summary published with the ongoing consultation", says one of the BP scientists.
Why were the Assay for Atorvastatin tablets selected as the case study? Atorvastatin tablets were selected because they are widely prescribed. "Diversity in the formulations and manufacturing methods used for the available products also made Atorvastatin tablets an ideal candidate for this study".
Is the goal of AQbD to have a “Design Space” for pharmacopoeial analytical procedures? In addition to the Design Space and the Analytical Target Profile (ATP), AQbD has many different benefits. "For example, the MHRA’s project has built an understanding of the Atorvastatin Tablet Assay procedures operable region". According to the BP scientists this could be taken to understand the edges of failure and implement specific elements of control to ensure robustness in use.
The project report seems to contain a substantial amount of work, could AQbD be too labour or time extensive to implement? Developing an analytical procedure using AQbD seems to generate greater cost when compared to traditional methodologies. Therefore, one aim of the project is to understand the resources required to implement AQbD concepts against the benefits. Potential savings could be achieved, for example, by using risk-based approaches to target analytical assessments to critical areas of a procedure.