Join the Analytical Quality by Design Working Party and work to shape the future of the Analytical method lifecycle

The Medicines and Healthcare products Regulatory Agency (MHRA) consulted on Analytical Quality by Design (AQbD) principles to pharmacopoeial standards for medicinal products and subsequently published its strategy in August 2020, with input from the British Pharmacopoeia (BP), MHRA, industry bodies and the Therapeutic Goods Administration (TGA) of Australia.

As part of the implementation of the strategy, the British Pharmacopoeia Commission is working to drive a variety of projects forward that set the scene for the future of analytical quality by design methods.

Central to the successful design and delivery of this work to date, has been the British Pharmacopoeia Commission’s dedicated Analytical Quality by Design working party. Since 2014, the working party has contributed the necessary experience, expertise and critical thinking needed to guide and deliver important projects to fruition, including a major practical case study, public consultation and the subsequent strategy, as well as the production of guidance for AQbD in the British Pharmacopoeia.

As the work continues into its next phase the British Pharmacopoeia Commission is looking to extend the professional membership of the working party with experts who can demonstrate specific experience and understanding of AQbD and the analytical method lifecycle to support with the following areas of work:

• Investigating the Analytical Target Profile concept further, including its application in a variety of situations.
• Investigating the application of Quality Risk Management and Experimental Design concepts for the assessment of a selection of critical quality attributes for medicinal products.
• Collaborating with our international peers to ensure alignment for the AQbD principles to support worldwide accessibility and understanding.
• Developing engaging workshops, seminars and forums to share knowledge across regulatory bodies, industry and academia.

Expressing interest in joining the Analytical Quality by Design Working Party

If you are interested in finding out more about joining the Analytical Quality by Design working party, complete our Expression of Interest forms and email it along with a copy of your CV to AQbDStds@mhra.gov.uk by 5:30 pm (BST) on Monday 28^th June 2021.