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."