The Medicines and Healthcare Products Regulatory Agency (MHRA) have opened a consultation on their plans to apply analytical quality by design (AQbD) principles to pharmacopoeial standards for medicines. The public consultation closes on 31st August 2019 and the MHRA hopes to learn about the opportunities and challenges relating to pharmaceutical quality, and how AQbD concepts are used by drug manufacturers.
The MHRA describes quality by design (QbD) as a “systematic approach to development that begins with predefined objectives and emphasises product and process understanding and process control, based on sound science and quality risk management.” For medicinal products in the United Kingdom (UK), pharmacopoeial standards are published in the British Pharmacopoeia (BP) and are an important component of a regulatory framework. Pharmacopoeial standards develop and evolve alongside advances in manufacturing science and technology, therefore the MHRA is exploring how AQbD principles may be applied to pharmacopoeial standards in collaboration with industry experts.
Before the consultation, the MHRA conducted a case study on atorvastatin which focussed on how AQbD principles could be applied to the development of a pharmacopoeial assay for the tablets.
The consultation highlights examples of a pharmacopoeial assay procedure presenting potential approaches that include an analytical target profile (ATP) and/or operable ranges alongside the procedure. The MHRA have asked medicine manufacturers to rank their preferences among the five examples for presenting assay procedures within the British Pharmacopoeia (BP).
The first example is a representation of the current style of assay procedure in the BP, and the other four examples present a procedure with operable ranges: a procedure with an ATP; a procedure with bother operable ranges and an ATP; and an ATP only.
The MHRA have stated that the AQbD approach may enable the BP to publish additional information regarding an analytical procedure to help ensure the procedure described in the monograph performs robustly in their laboratory. Or alternatively to outline the performance requirements which the monograph procedure has been designed to meet, potentially allowing users to justify the adoption of alternative methods that have been shown to meet the performance requirements in the ATP.
To read the MHRA consultation on the application of AQbD principles to pharmacopoeial standards for medicines, please click here.