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MHRA has launched a consultation to gain a greater understanding of the potential application of AQbD in pharmacopoeial standards and the future of medicines standards.
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation to gather views on the application of Analytical Quality by Design (AQbD) principles to pharmacopoeial standards in the British Pharmacopoeia (BP). This consultation considers the value of providing additional method understanding within monographs and of including method criteria, such as the Analytical Target Profile (ATP), to complement pharmacopoeial methods.
The MHRA is committed to ensuring the quality of medicines in the United Kingdom through its activities in the development of public quality standards. These standards are published in the BP and enable users to make an objective assessment in relation to the quality of a material. Pharmacopoeial standards are a key component of an interlinked regulatory framework, which ensures that safe and efficacious treatments are available to patients.
Pharmacopoeial standards evolve with advances in manufacturing science and technology. Therefore, the MHRA is exploring how AQbD principles may be applied to pharmacopoeial standards, in collaboration with other regulatory peers and industry experts, to help shape the future of pharmacopoeial standards.
The MHRA’s case study applied AQbD approaches to the development and verification of a high-performance liquid chromatography (HPLC) based pharmacopoeial Assay procedure for atorvastatin tablets.
Several different techniques to build method knowledge were used to give an assurance of the procedure’s robustness and crucially for the pharmacopoeia, ensure suitability of the method for the range of products available to patients. These included:
The case study confirmed that the application of the above techniques through closer collaboration with the manufacturer has the potential to deliver benefits to the users of the BP and aid the evolution of the pharmacopoeia. The learnings from the case study have come together to shape the ongoing consultation, which consists of a project summary, a survey with feedback form, and visual examples of the application of these principles.
A technical report of this case study, detailing the laboratory based investigations to date, is also published with the consultation on the UK government’s website: “Consultation on the application of Analytical Quality by Design (AQbD) principles to pharmacopoeial standards for medicines.”
To date, the project has revealed the following key issues:
Through the consultation the Agency aims to understand stakeholder views on the future for the quality of medicines, the level of expertise and experience with AQbD, views on how AQbD could be useful for standards, and comments on the example approaches. Pharma industry participants are invited to provide their individual opinions as well as coordinated organisational responses. A dedicated inbox has been set up to support this consultation so please direct any comments or queries to AQBDStds@mhra.gov.uk.
The consultation closes on the 31 August 2019, after which the Agency will compile and review responses to define policy on the application of AQbD principles and the evolution of pharmacopoeial standards.
1. ICH, Q8 (R2) Pharmaceutical Development, Step 4 version (August 2009).