ABSTRACT:
The concept of Analytical Quality by Design (AQbD) extends the principles of Quality by Design (QbD) to ensure analytical methods are robust and fit for their intended purposes. An important aspect of this approach is the emphasis on a scientific, risk-based methodology, which examines the method's performance characteristics and their influences. In contrast to traditional approaches, which heavily rely on validation and testing, the AQbD approach integrates quality into the design phase of analytical procedures. Critical analytical attributes (CAAs) and critical method parameters (CMPs) are the core of AQbD. Analytical methods must accurately measure CAAs, whereas CMPs are variables that can influence these measurements. In order to establish a method's design space—a defined range in which the method performs reliably—an analyst can systematically examine the relationships between CMPs and CAAs. As part of the AQbD process, an analytical target profile (ATP) is defined, risk assessments are conducted, design of experiments (DOE) are used to explore method parameters, and multivariate data analysis is used to optimize the performance of the method. Through this approach, robust methods can be developed that deliver consistent, accurate, and reliable results. Many advantages can be gained by implementing AQbD in the development of analytical methods, including increased robustness, improved regulatory compliance, and greater operational flexibility. By including quality considerations from the start, AQbD ensures that analytical procedures are not only efficient and reliable, but also flexible to changing conditions. This eventually leads to improved control over product quality and consistency in pharmaceutical manufacturing, which aligns with the industry's purpose of delivering safe and effective medicines.