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Abstract：
Food manufacturers are required to obtain scientific and technical evidence that a control measure or combination of control measures is capable of reducing a significant hazard to an acceptable level that does not pose a public health risk under normal conditions of distribution and storage. A validation study provides evidence that a control measure is capable of controlling the identified hazard under a worst-case scenario for process and product parameters tested. It also defines the critical parameters that must be controlled, monitored, and verified during processing. This review document is intended as guidance for the food industry to support appropriate validation studies, and aims to limit methodological discrepancies in validation studies that can occur among food safety professionals, consultants, and third-party laboratories. The document describes product and process factors that are essential when designing a validation study, and gives selection criteria for identifying an appropriate target pathogen or surrogate organism for a food product and process validation. Guidance is provided for approaches to evaluate available microbiological data for the target pathogen or surrogate organism in the product type of interest that can serve as part of the weight of evidence to support a validation study. The document intends to help food manufacturers, processors, and food safety professionals to better understand, plan, and perform validation studies by offering an overview of the choices and key technical elements of a validation plan, the necessary preparations including assembling the validation team and establishing prerequisite programs, and the elements of a validation report.
摘要：
食品制造商必须获得科学和技术证据，证明控制措施或控制措施的组合能够将重大危害降低到可接受的水平，在正常的分配和储存条件下不会造成公共卫生风险。验证研究提供的证据表明，控制措施能够在测试的过程和产品参数的最坏情况下控制已识别的危险。它还定义了必须控制的关键参数，监控,并在处理过程中验证。本审查文件旨在作为食品行业的指导，以支持适当的验证研究，并旨在限制食品安全专业人员之间可能发生的验证研究的方法学差异，顾问,第三方实验室该文件描述了设计验证研究时必不可少的产品和工艺因素，并给出选择标准，以确定食品和工艺验证的适当目标病原体或替代生物体。提供了用于评估目标产品类型中目标病原体或替代生物体的可用微生物数据的方法的指导，这些数据可以作为支持验证研究的证据重量的一部分。该文件旨在帮助食品制造商，处理器,和食品安全专业人士更好地了解，plan,并通过提供验证计划的选择和关键技术要素的概述来进行验证研究，必要的准备工作，包括组建验证团队和建立先决条件，和验证报告的元素。
