MTS Recommends... Application of QbD and QRM to Analytical Method Validation

W. Saffell-Clemmer and J. Karty, "Application of QbD and QRM to Analytical Method Validation,"
Pharmaceutical Technology 40 (11) (November 2016).

"To further understanding of QbD concepts to analytical method development and validation, the tools suggested in the Stimuli article were combined with the guidance in ICH Q2(R1) for this case study, and applied to the validation of a stability-indicating high-performance liquid chromatography (HPLC) method for Protopam drug substance (Baxter) and Protopam chloride for injection meeting ICH Q3A(R2) and ICH Q3B(R2) standards for impurities."