Elements of Quality by Design in Development and Scale-Up of Freeze-Dried Parenterals

摘要

The US Food and Drug Administration's Quality by Design (QbD) initiative is a new regulatory philosophy based on pre-defined quality targets and a deep understanding of how formulations and processes interact to influence critical quality attributes of pharmaceutical products.1 This understanding is based on: prior knowledge of unit operations used in manufacturing a product, experimental data from development work, and published literature. In contrast, many submissions are based on empirical determination of performance criteria from analysis of experimental data.