Last month, this column began exploring the following three fundamental options for when the commissioning professional prepares customized functional performance test procedures for a project. During ...
This eBook explores the evolution of HPLC from a breakthrough analytical technique into a modern, software-assisted framework for Analytical Quality by Design (AQbD). Through expert perspectives and ...
ICH Q14 proposes to harmonize analytical procedure development The 64-page ICH Q14 document proposes to harmonize the scientific approaches for analytical procedures development by describing a ...
Critical areas including: - the new ICH Q14 and ICH Q2 guideline updates, and other guidelines/chapters such as the BP / JP chapters and the upcoming USP chapters 1220>, 1221> and 1225>. - covering ...
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