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Q2(R2) Validation of Analytical Procedures August 2022


Not for implementation. Contains non-binding recommendations.

Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research, Office of Regulatory Policy

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. Q2(R2) provides guidance and recommendations on how to derive and evaluate the various validation tests for each analytical procedure. This guideline serves as a collection of terms, and their definitions. These terms and definitions are meant to bridge the differences that often exist between various compendia and documents of the ICH member regulatory agencies.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-1503.

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