This guideline presents elements for consideration during the validation of analytical procedures included as part of registration applications. Analytical procedure validation forms a part of the analytical procedure lifecycle, as described within ICH Q14 Analytical Procedure Development. ICH Q2(R2) provides guidance on selection and evaluation of the various validation tests for analytical procedures. This guideline includes a collection of terms and their definitions, which are meant to bridge the differences that often exist between various compendia and documents of the ICH member
regulatory authorities.
The objective of validation of an analytical procedure is to demonstrate that the analytical procedure is fit for the intended purpose. Further general guidance is provided on validation studies for analytical procedures.
1.2 Scope
This guideline applies to analytical procedures used for release and stability testing of commercial drug substances and products, hereafter referred to as ‘products’. The guideline can also be applied to other analytical procedures used as part of the control strategy (ICH Q10 Pharmaceutical Quality System)
following a risk-based approach. The scientific principles described in this guideline can be applied in a phase-appropriate manner to analytical procedures used during clinical development.
The guideline is directed to common uses of analytical procedures, such as assay, potency, purity, impurity (quantitative or limit test), identity or other quantitative or qualitative measurements.