Module 3 2019

Drug Substance Assay Robustness •

“measure of its capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication of reliability during normal usage” e.g (ICH) • e.g. for chromatographic methods: pH, temperature, columns and supplier, mobile phase composition • Univariate or multivariate approach. • Univariate approach is conceptually simple and often quicker – has been acceptable by regulators historically. • Multivariate – should provide more information. Perception that this may be slower but correct design can lead to understanding of interactions between parameters. Commercial software readily available to help guide design. • Both methods useful for estimating reliability (and transferability) and also for assessing system suitability parameters (in conjunction with data through routine use).

Questions:

• Is an understanding of Robustness more important than an understanding of Ruggedness?

The Organisation for Professionals in Regulatory Affairs

• Implications of QbD for Analytical Methods?