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GUIDANCE DOCUMENT

CVM GFI #208 (VICH GL49) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of Analytical Methods Used in Residue Depletion Studies March 2015

Final
Docket Number:
FDA-2010-D-0165
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

During the veterinary drug development process, residue depletion studies are conducted to determine the concentration of the residue or residues present in the edible products (tissues, milk, eggs or honey) of animals treated with veterinary drugs. This information is used in regulatory submissions around the world. Submission of regulatory methods (i.e., post approval control methods) and the validation requirements of the regulatory methods are usually well defined by various regulatory agencies worldwide and might even be defined by national or regional law. However, the residue depletion studies are generally conducted before the regulatory methods have been completed. Oftentimes the in-house validated residue methods provide the framework for the methods submitted for regulatory monitoring. Harmonization of the validation requirements for methodology used during residue depletion studies and submitted to the regulatory agencies in support of the maximum residue limits (MRLs) and withdrawal periods should be achievable. It is the intent of this document to describe a validation procedure that is acceptable to the regulatory bodies of the VICH regions for use in the residue depletion studies..

A variety of validation guidances exist for analytical methodology and many of the aspects of those validation procedures are incorporated in this document (Guidance for Industry (GFI) #63, “Validation of Analytical Procedures: Definition and Terminology” (VICH GL1) and GFI #64, “Validation of Analytical Procedures: Methodology” (VICH GL2), July 1999). However, there are aspects of residue validation procedures that are addressed in this guidance document that are not addressed in previous documents. The guidance provided here is intended to specifically address the validation of veterinary drug residue methods.


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All written comments should be identified with this document's docket number: FDA-2010-D-0165.

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