CVM GFI #64 (VICH GL2) Validation of Analytical Procedures: Methodology August 2024

GUIDANCE DOCUMENT

• Docket Number: FDA-2021-D-0616
• Issued by: 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.

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