ICH Q2(R2) Validation of analytical procedures - Scientific guideline
This guideline presents a discussion of elements for consideration during the validation of analytical procedures included as part of registration applications submitted within the ICH member regulatory authorities. It provides guidance and recommendations on how to derive and evaluate the various validation tests for each analytical procedure and serves as a collection of terms, and their definitions. This guideline applies to new or revised analytical procedures used for release and stability testing of commercial drug substances and products (chemical and biological/biotechnological). The guideline can also be applied to other analytical procedures used as part of the control strategy following a risk-based approach. The guideline is directed to the most common purposes of analytical procedures, such as assay/potency, purity, impurities), identity and other quantitative or qualitative measurements.
Keywords: Validation, analytical procedures, accuracy, precision, specificity, detection limit, quantitation limit, linearity, range
ICH guideline Q2(R2) on validation of analytical procedures - Step 2b (PDF/872.17 KB)Draft: consultation closed
First published: 01/04/2022
Consultation dates: 31/03/2022 to 31/07/2022
Overview of comments received on ICH guideline Q2(R2) on on ICH guideline on Q2(R2) validation of analytical procedures (EMA/CHMP/ICH/82072/2006) (PDF/658.82 KB)
First published: 24/08/2022