Formulation and Quality – Chemical
2019 PharmSci 360
Analytical method developed based on quality by design (QbD) concept provides better method performance and enhanced method understanding, which leads to less method failures and better regulatory communications. Adopting the QbD concept requires us to change the workflow on method development and characterization, and thus posts some new challenges. Fortunately, there are some technology and software tools that can be used to facilitate the adoptation process. In this presentation, we will use HPLC methods as examples to discuss the application of these tools across all stages of the analytical procedure lifecycle. Specifically, we will discuss the following topics: 1) Selection of mobile phases and stationary phase; 2) method optimization; 3) DOE method robustness evaluation; 4) method transfer and 5) continuous method performance verification.