HPLC Assay Method Validation - The Complete ICH-Aligned Reference

HPLC Assay Method Validation

The Complete ICH-Aligned Reference

ICH-aligned HPLC assay validation, explained parameter by parameter, with acceptance criteria.

Description

Validation fails audits not because the science is wrong, but because a parameter was misunderstood, an acceptance criterion was set badly, or the rationale wasn't documented defensibly.

This guide walks every assay validation parameter, specificity, linearity, accuracy, precision, range, robustness, the way a regulator expects to see it: what it proves, how to design the study, what acceptance criteria to apply, and how to document it so it holds up.

What's inside

•    Every ICH Q2 assay validation parameter, explained in plain terms

•    How to set defensible acceptance criteria (and why the common ones fail)

•    Study design, sample number, and the statistics you actually need

•    Documentation structured to survive an audit

Who it's for: QC and analytical development scientists validating assay methods to ICH / USP / FDA expectations.

The standalone guide. For the guide plus the working templates and worksheets, see the HPLC Assay Validation Toolkit.