ICH Analytical Procedure Validation Guidance

FDA has published an International Council for Harmonization (ICH) guidance, Q2(R2) Validation of Analytical Procedures, with elements for consideration during the validation of analytical procedures included as part of registration applications. The document includes a collection of terms and their definitions that 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,” the guidance says. “Further general guidance is provided on validation studies for analytical procedures.”

The guidance applies to analytical procedures used for release and stability testing of commercial drug substances and products. It can also be applied to other analytical procedures used as part of the ICH control strategy guidance for industry (Q10) following a risk-based approach.