Application of Analytical Quality by Design concepts to pharmacopoeial standards for medicines

In June 2019, the Medicines and Healthcare products Regulatory Agency (MHRA) published a consultation to understand the views of stakeholders on the application of Analytical Quality by Design (AQbD) concepts to pharmacopoeial standards. This was accompanied by technical review of an MHRA project that had explored the application of AQbD to a pharmacopoeial Assay procedure. 

The consultation was received positively by stakeholders with a wide range of responses representing trade associations, manufacturers, academia and researchers, and peer organisations. Following the consultation, the MHRA published a clear position on the value of applying AQbD together with a strategy to implement the consultation outcomes.

The consultation ran from June 2019 to August 2019. The public response to the consultation was published in August 2020. 

The consultation, technical review and response documents can be found here