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FDA CVM GFI #118 Mass Spectrometry for Confirmation of Identity of Animal Drug Residues

蒋千琴 1/19/2022 浏览 241 FDA 美国

标准简介

CVM GFI #118 Mass Spectrometry for Confirmation of Identity of Animal Drug Residues[附网盘链接]是于不久前发布的FDA标准，适用于美国。

标准截图

CVM GFI #118 Mass Spectrometry for Confirmation of Identity of Animal Drug Residues[附网盘链接]
CVM GFI #118 Mass Spectrometry for Confirmation of Identity of Animal Drug Residues[附网盘链接](截图)

 

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标准部分原文

FINAL GUIDANCE FOR INDUSTRY: MASS SPECTROMETRY FOR CONFIRMATION OF THE IDENTITY OF ANIMAL 1 DRUG RESIDUES

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing the guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. I. INTRODUCTION CVM develops, evaluates, and applies qualitative mass spectrometric methods for confirming the identity of animal drug residues. Methods developed in support of a New Animal Drug Application (NADA methods) are designed for residues of an approved new animal drug used in the approved manner. Methods may also be developed for unapproved new animal drugs or approved new animal drugs used in an unapproved manner (non-NADA methods). This final guidance document describes the basic principles recommended by CVM for developing, evaluating and applying these methods. The purpose of this document is to facilitate and expedite coordination between CVM and its stakeholders so these activities may be carried out in a consistent and timely manner. This final document does not commit CVM to accepting a specific method or data package prior to reviewing the relevant data. This final document is intended for technical professionals familiar with mass spectrometry. Please contact CVM for further information on this document or any technical explanations that may be necessary. For a historical perspective, please see the Bibliography. For definitions of terms used in this document, please see the Glossary. This guidance document is applicable in the following areas: 1. Consultations on confirmatory methodology 2. Desk reviews of confirmatory procedures 3. Method trials or second-laboratory evaluations of confirmatory procedures 4. Development of confirmatory procedures 1

This guidance has been prepared by the Division of Residue Chemistry, Office of Research, Center for Veterinary Medicine (CVM) at the Food and Drug Administration.

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