Analytical Quality by Design Guidance (AQbD)

Feel confident in applying AQbD concepts with minimal risk

The Analytical Quality by Design (AQbD) Supplementary Chapter provides guidance on how to enhance method understanding by 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.  

Understanding how AQbD concepts are applied will: 

  • ensure implementation of robust methods; 

  • save time in the laboratory by targeting experimentation to the relevant method conditions. 

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.  

The Atorvastatin Tablets monograph in the upcoming BP 2023 has been developed using AQbD concepts. The BP Supplementary Chapter X provides guidance to help you adopt these concepts.

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