CVM GFI #73 (VICH GL3(R)) Stability Testing of New Veterinary Drug Substances and Medicinal Products November 2007

GUIDANCE DOCUMENT

• Docket Number: FDA-2006-D-0299
• Issued by: Center for Veterinary Medicine

The following document is a revised version of VICH GL3 and provides guidance regarding the stability data package for a new veterinary drug substance and medicinal product to be included in a registration application submitted within the three regions of the European Union (EU), Japan, and the United States. 

The guidance seeks to exemplify the core stability data package for new veterinary drug substances and medicinal products, but leaves sufficient flexibility to encompass the variety of different practical situations that may be encountered due to specific scientific considerations and characteristics of the materials being evaluated.  Alternative approaches may be used when there are scientifically justifiable reasons.

Specific details of the sampling and testing for particular dosage forms in their proposed container closures are not covered in this guidance.

Further guidance on new dosage forms, medicated premixes, and on biotechnological/biological products can be found in VICH guidances GL4, GL8, and GL17, respectively. Stability testing following first use of the product (e.g., first broaching of a vial) is not covered within this guidance.

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Dockets Management
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5630 Fishers Lane, Rm 1061
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All written comments should be identified with this document's docket number: FDA-2006-D-0299.

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