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.