Open consultation

Consultation on the application of Analytical Quality by Design (AQbD) principles to pharmacopoeial standards for medicines

Summary

This consultation asks for views on the application of AQbD principles to pharmacopoeial standards for medicinal products.

This consultation closes at

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

Application of Analytical Quality by Design concepts to pharmacopoeial standards for medicines

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Response form

This file may not be suitable for users of assistive technology. Request an accessible format.

If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Published 4 June 2019