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GUIDANCE DOCUMENT

CVM GFI #63 (VICH GL1) Validation of Analytical Procedures: Definition and Terminology July 1999

Final
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 on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002