Qualified Reference Standards: Setting The Standard For Product Quality

By Darryl A. LeBlanc, PhD, Principal Scientist, Analytical Services

Drug producers face increasing stringency from regulatory authorities to substantiate the purity of drug products and to demonstrate control of impurities. Qualified reference standards play a critical role in providing validated benchmarks to satisfy regulatory requirements pertaining to purity. Additionally, they equip manufacturers with information they can apply to solve issues and to assess the impact of changes to the manufacturing process.

As drugs progress toward IND and NDA filing milestones, qualified reference standards must be produced in quantities sufficient to support analytical and process development studies. When drug manufacturers are navigating the competing pressures of time and budget limitations alongside regulatory constraints, they may undervalue the benefit of applying thorough and rigorous characterization efforts early in the development pipeline.

An experienced CDMO can connect the value of investing in qualified reference standards to the impact on final product quality. Profiling impurities allows manufacturers to isolate and identify them if problems arise. Armed with an accurate understanding of an impurity and its specific characteristics, they can design a solution to fix a problem without retracing steps to characterize the impurity.