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GUIDANCE DOCUMENT

CVM GFI #63 (VICH GL1) Validation of Analytical Procedures: Definition and Terminology August 2024

Download the Final Guidance Document
Final
Docket Number:
FDA-2021-D-0614
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This guidance document provides guidance on characteristics for consideration during the validation of the analytical procedures included as part of registration applications for approval of veterinary medicinal products submitted to the European Union, Japan, and the United States. 

The discussion of the validation of analytical procedures is directed to the four most common types of analytical procedures:

  • Identification tests.
  • Quantitative tests for impurities content.
  • Limit tests for the control of impurities.
  • Quantitative tests of the active moiety in samples of drug substance or drug product or other selected component(s) in the drug product.

Submit Comments

Submit Comments Online

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-2021-D-0614.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002
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