ICH & USP <1220>: Implementing A QbD Analytical Framework

By Brian Glass, Pharmatech Associates

The International Council for Harmonization (ICH) and the United States Pharmacopoeia (USP) are currently finalizing draft guidelines that describe a new paradigm for analytical development based on the quality by design (QbD) approach used for pharmaceutical development. These guidelines describe the analytical life cycle management approach for the development, validation, and continuous monitoring of analytical procedures using QbD principles.

Continuous monitoring of methods is a shift that represents a significant difference in thinking for drug sponsors and their CDMO partners, as they bring pharmaceutical and biopharmaceuticals products to market. Classical analytical procedures lend themselves well to these systems, and processes involving cell-based assays are also amenable but require more thought. An analytical life cycle approach offers many advantages for drug sponsors and CDMOs. It provides a structure for analytical development and expands the knowledge base to identify critical method parameters useful in streamlining robustness experiments, and it allows for continuous performance monitoring of the method over time.