MHRA consultation on application of AQbD principles enters last month

The UK Medicines and Healthcare products Regulatory Agency’s (MHRA’s) three-month public consultation on the application of Analytical Quality by Design (AQbD) principles to pharmacopoeial standards is due to close for comment on 31 August 2019.

Pharmacopoeial standards are a key component of a regulatory framework. For medicinal products in the UK they are published in the British Pharmacopoeia (BP), a publication of the MHRA. Pharmacopoeial standards evolve with advances in manufacturing science and technology.

Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasises product and process understanding and process control, based on sound science and quality risk management. As a concept, it aims to assure the quality of medicines by using enhanced approaches to design, development and manufacture of medicinal products. When the QbD approach is applied to analytical methods, it is termed Analytical Quality by Design.

Therefore, the MHRA, in collaboration with industry experts, has been exploring how AQbD principles could be used to evolve pharmacopoeial standards through a practical case study developing an assay procedure for atorvastatin tablets. A review of this case study including key benefits is detailed in a technical report accompanying the consultation.

The consultation aims to understand the views of all interested stakeholders on the use of AQbD as well as comment on if and how they should be applied to pharmacopoeial standards.