The MHRA opened a three-month public consultation (until August 31, 2019) on its plans to apply analytical quality by design (AQbD) principles to its pharmacopoeia.
According to ICH Q8, Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management (QRM). The application of QbD principles to analytical methods is currently being highly dscussed by industry, regulators and scientists.
Compendia (like, for example, Ph. Eur. and USP) are a key component of a regulatory framework. For medicinal products in the UK pharmacopoeial standards are published in the British Pharmacopoeia (BP). Since pharmacopoeial standards develop with advances in manufacturing science and technology, the MHRA has explored how AQbD principles may be applied to pharmacopoeial standards in collaboration with industry experts. Therefore, the 15 page consultation paper includes a series of examples to illustrate the potential models for inclusion in the pharmacopoeia.
Find out more here.