Consultation on the application of Analytical Quality by Design (AQbD) principles
Public 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. Public standards evolve with advances in manufacturing science and technology. Therefore, the MHRA has explored how Analytical Quality by Design (AQbD) principles may be applied to public standards in collaboration with industry experts.
This consultation is to understand the views of Agency stakeholders on the application of AQbD principles to public standards and includes a series of examples to illustrate the potential models for inclusion in the pharmacopoeia. The consultation runs until 31 August 2019 on our website at: https://www.gov.uk/government/consultations/consultation-on-the-application-of-analytical-quality-by-design-aqbd-principles-to-pharmacopoeial-standards-for-medicines.
Queries about the consultation can be emailed to AQbDStds@mhra.gov.uk.