MHRA Consults on Analytical Quality by Design Principles
The UK’s Medicines and Health care products Regulatory Agency (MHRA) on Tuesday opened a three-month public consultation on its plans to apply analytical quality by design (AQbD) principles to its pharmacopoeial standards.“Quality by Design (QbD) is 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,” MHRA writes.
The consultation follows the exploration of AQbD in the International Council for Harmonization’s (ICH) recently released concept paper ICH Q14: Analytical Procedure Development and Revision of Q2(R1) Analytical Validation last November.
Ahead of the consultation, MHRA conducted a case study that focused on how AQbD principles could be applied to the development of a pharmacopoeial assay procedure for atorvastatin tablets.
The consultation features a description of the case study and its outcomes as well as five examples of a pharmacopoeial assay procedure presenting potential approaches that include an analytical target profile (ATP) and/or operable ranges alongside the procedure.
The first of the five examples is a representation of the current style of assay procedure in the British Pharmacopoeia (BP), with the remaining four examples presenting a procedure with operable ranges; a procedure with an ATP; a procedure with both operable ranges and an ATP; and an ATP only.
“The AQbD approach has the potential to enable the BP to publish additional information about an analytical procedure to help users ensure the procedure described in the monograph performs robustly in their laboratory or to describe the performance requirements that the monograph procedure has been designed to meet, potentially enabling users to justify the adoption of alternative methods that have been shown to meet the performance requirements in the ATP,” MHRA writes.
The consultation asks drugmakers to rank their preferences among the five examples for presenting assay procedures within the BP.
With the consultation MHRA also hopes to learn about the opportunities and challenges relating to pharmaceutical quality over the next five years and how AQdB concepts are used by drugmakers.
MHRA