Guidance materials

Analytical Quality by Design Guidance (AQbD)

Why are we exploring AQbD?

Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasises product and process understanding and process control, based on sound science and quality risk management.

As a concept, it aims to assure the quality of medicines by using enhanced approaches to design, development and manufacture of medicinal products. The application of QbD principles to analytical methods, Analytical Quality by Design (AQbD), is being explored by industry, regulators, and academia.

Pharmacopoeial 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. Pharmacopoeial standards evolve with advances in the manufacture of medicinal  products.

The MHRA is exploring how AQbD may apply to pharmacopoeial standards through the BP’s AQbD working party, which brings together BP scientists with MHRA assessors and inspectors as well as the Therapeutic Goods Administration of Australia (TGA), multinational biopharmaceutical manufacturers, the generics manufacturing industry and experts in the field of metrology.

More robust methods

An initial case study focussed on the practical application of AQbD principles to the development of an analytical procedure for the Assay of Atorvastatin in Atorvastatin Tablets.  This monograph was published in the BP 2023 along with the additional method understanding we gained through the application of enhanced approaches.

This additional method understanding will:

  • provide assurance of the Assay procedure;
  • highlight sensitivities of the analytical procedure.

We are now considering how learnings from this case study can be applied to our routine monograph development process to enhance method robustness and method understanding across BP monographs.

Feel confident in applying AQbD concepts with minimal risk

The BP’s AQbD Working Party also developed and published in the BP 2022 the Analytical Quality by Design (AQbD) Supplementary Chapter X which provides guidance on how to enhance method understanding by adopting AQbD concepts in analytical methods.  

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. 

The guidance will help you ensure that the analytical methods you use are robust and fit-for-purpose. This will enable a better assessment of product quality, and ultimately provide greater assurance to safeguard patient safety.

You can access the guidance and Atorvastatin Tablets monograph in the BP online. If you do not have access you can purchase BP Online 2024.