Consultation on the application of Analytical Quality by Design (AQbD) principles to pharmacopoeial standards for medicines
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Detail of outcome
The Medicines and Healthcare products Regulatory Agency is now able to publish a clear position on the value of the application of Analytical Quality by Design (AQbD) to pharmacopoeial standards for medicines. This position, underpinned by a strategy that will implement the outcomes of a consultation carried out last summer, will support and complement the evolution of developing regulatory science in this field and ensure global regulatory alignment and consistency. The following four strategic objectives have been identified:
- Develop and publish new standards and guidance.
- Further explore the application of AQbD concepts.
- Build capability across the Agency.
- Engage and collaborate with stakeholders.
These objectives will be delivered through a work programme structured around important themes raised by respondents: supporting and enabling innovation; laying out a process for robust inclusion of AQbD in public quality standards for the UK and encouraging collaboration, engagement and knowledge transfer.
The Agency is committed to ensuring the quality of medicines through its activities in the development of public quality standards that help to assure the safety and efficacy of medicines. Responses supported the role that AQbD can play in ensuring quality through the provision of robust analytical methods, which underpins the assurance of medicines’ safety and efficacy.
Original consultation
Consultation description
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.
As a concept, it aims to assure the quality of medicines by using enhanced approaches to design, development and manufacture of medicinal products. The application of QbD principles to analytical methods is being explored by industry, regulators and academia.
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, so the MHRA has explored how Analytical Quality by Design (AQbD) principles may be applied to pharmacopoeial standards in collaboration with industry experts.
This consultation is to understand the views of Agency stakeholders on the application of AQbD principles to pharmacopoeial standards and includes a series of examples to illustrate the potential models for inclusion in the pharmacopoeia.
The consultation is supported by a technical report which provides a critical review of the project, while introducing initial key outcomes and conclusions.
Documents
Updates to this page
Last updated 12 August 2020 + show all updates
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The final outcome of the consultation has been added.
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First published.