Issue Date: November 7, 2005
Issued by: Center for Veterinary Medicine
Topic(s): Animal Feed, Chemistry, Manufacturing, and Controls (CMC)
Status: Final
CVM GFI #135 Validation of Analytical Procedures for Type C Medicated Feeds
Section 512(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360b) establishes the requirements for new animal drug approval. 21 CFR 514.1 specifies the information required to be submitted as part of the application and the proper form for the submission. Section 514.1(b)(5)(vii) requires an applicant to describe analytical procedures that should be capable of determining the active component(s) within a reasonable degree of accuracy and of assuring the identity of such components. Section 514.1(b)(5)(vii)(a) states that a description of practicable methods of analysis of adequate sensitivity to determine the amount of the new animal drug in the final dosage form should be included. The purpose of this guidance is to provide recommendations on how to consider the various validation characteristics for each analytical procedure used in medicated feed assays. This guidance is written primarily for chromatographic methods; however, the guidance does not limit the analytical technique to chromatographic procedures, as other techniques may be appropriate. 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 medicated feed.
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