Definitions and scope of Analytical Quality by Design (AQbD) key elements for method development in the pharmaceutical industry

Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02162 | Published on: 05/10/2023

Abstract

Introduction: The pharmaceutical sector is constantly evolving and is highly regulated with rules to ensure efficacy, safety and quality of medicines. Quality by Design (QbD) is a systematic approach to pharmaceutical development, grounded in scientific knowledge and risk management associated with the manufacturing process. Applied to the development of analytical procedures, QbD has been called Analytical Quality by Design (AQbD) and becomes a process for outlining more robust procedures, applicable throughout the life cycle of the product with a reduction in the incidence of out of trend results or out of specification, related to the method. Objective: Clarify the concepts of AQbD and the scope of its key elements for alignment within the pharmaceutical industry. Method: Search in databases of scientific articles, as well as national and international guides on the subject. Results: AQbD elements include: (1) analytical target profile; (2) identification of critical attributes and critical parameters of the analytical procedure; (3) development, optimization and understanding of the analytical procedure; (4) robustness and definition of the method operable design region; (5) control strategy that includes specifications as well as necessary controls. AQbD values prior knowledge, applies risk assessment and experiment planning during the design of the analytical procedure. Conclusions: As the pharmaceutical industry moves towards the implementation of AQbD, a common terminology, understanding of concepts and expectations are needed, which will facilitate better communication between those involved in drug development, including regulatory agencies.