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CVM GFI #64 (VICH GL2) Validation of Analytical Procedures: Methodology: Final Guidance July 1999

Docket Number:
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This guidance is complementary to GFI #63 (VICH GL1), which presents a discussion of the characteristics that should be considered during the validation of analytical procedures. The purpose of this document is to provide some guidance and recommendations on how to consider the various validation characteristics for each analytical procedure included as part of a registration application for approval of veterinary medicinal products submitted to the European Union, Japan, and the United States.  In some cases (for example, demonstration of specificity), the overall capabilities of a number of analytical procedures in combination may be investigated in order to ensure the quality of the drug substance or drug product. In addition, the document provides an indication of the data which should be presented in a registration application.

Submit Comments

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-0616.


Contact Point
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
(240) 402-7002
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