AQbD guidance is now live on BP online
The Analytical Quality by Design (AQbD) supplementary chapter provides best practice guidance on how to enhance method understanding by successfully adopting AQbD concepts in analytical methods.
BP scientists have worked together with MHRA assessors and inspectors as well as the Therapeutic Goods Administration of Australia (TGA), multinational biopharmaceutical manufacturers, the generics manufacturing industry and from the field of metrology to provide this guidance.
Available now in the British Pharmacopoeia (BP) 2022 edition, the guidance will help you ensure that the analytical methods used are robust and fit-for-purpose. This will enable a better assessment of product quality, and ultimately provide greater assurance to safeguard patient safety.