ISO/TS 23758:2021 牛奶和奶制品中兽药残留检测的定性筛选方法验证指南

标准编号：ISO/TS 23758:2021

中文名称：牛奶和奶制品中兽药残留检测的定性筛选方法验证指南

英文名称：Guidelines for the validation of qualitative screening methods for the detection of residues of veterinary drugs in milk and milk products

发布日期：2021-08

标准范围

本文件描述了用于检测液态奶（生的、巴氏杀菌的、UHT和重组奶粉以及乳清蛋白提取物）中兽药残留的定性筛选试验的验证和验证的一般工作流程和协议，包括生物方法。本指南不包括通过HPLC、UHPLC或LC-MS/MS进行残留分析的验证。本文件适用于筛查试剂盒制造商、验证筛查方法或测试的实验室、主管部门和乳品厂，或检测乳制品中兽药残留的试剂或测试的最终用户。本文件有助于并改进筛选方法的验证和验证。本文件的目标是协调方法或检测试剂盒的验证，以便所有利益相关者对残留筛选结果有充分的信任，并通过共享独立实验室生成的验证结果，限制不同实验室验证工作的重叠和倍增。此外，协调的验证和验证程序允许比较不同筛查方法的性能。本文件并不意味着所有最终用户都必须执行所有建议的验证工作。验证用于检测抗菌剂的试剂/试剂盒的正确使用不属于本文件的范围。

This document describes general workflows and protocols for the validation and the verification of qualitative screening tests for the detection of residues of veterinary drugs in liquid milk (raw, pasteurized, UHT and reconstituted milk powders and whey protein extracts) including biological methods. This guideline does not cover the validation of residue analysis by HPLC, UHPLC or LC-MS/MS.This document is intended to be useful for manufacturers of screening test kits, laboratories validating screening methods or tests, competent authorities and dairies or end users of reagents or tests for the detection of veterinary drug residues in milk products. This document facilitates and improves the validation and verification of screening methods. The goals of this document are a harmonization in validation of methods or test kits in order for all stakeholders to have full trust in the result of residue screening and to limit the overlap and multiplication of validation work in different laboratories by sharing the validation results generated by an independent laboratory. Furthermore, a harmonized validation and verification procedure allows for comparison of the performance of different screening methods.This document does not imply that all end users are bound to perform all verification work proposed.The verification of the correct use of reagents/kits for the detection of antimicrobials is not part of the scope of this document.

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