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.
Highlights
Foodborne illnesses due to consumption of foods contaminated with foodborne pathogens pose a significant public health problem (WHO, 2015)
Aryani et al (2015) quantified in detail the heat resistance of 20 L. monocytogenes strains in broth (Aryani et al, 2015; Figure 4c) and reported a slightly lower z-value than the reported z-values in milk and in other products that were based on a meta-analysis (Den Besten & Zwietering et al, 2012; Van Asselt & Zwietering, 2006), whereas the average D60-values were rather comparable in these different datasets
This includes (i) the rationale for the experimental study design, the number of replicates, and samples tested; (ii) the rationale for the selected target pathogen(s) or nonpathogenic surrogate and the data to substantiate its suitability as a surrogate for the target pathogen for each specific product and process being validated; (iii) information on the preparation of the inoculum and inocu
Summary
Foodborne illnesses due to consumption of foods contaminated with foodborne pathogens pose a significant public health problem (WHO, 2015). This guidance is intended to provide a reference for the food industry to validate the effectiveness of process controls within their food safety plans The objective of this initiative was to develop practical and easy-to-use protocols for validation studies to control foodborne pathogens in various food matrices during processing and manufacturing. The objective of this document is to improve the overall understanding of validation processes in practice and help to establish an industry-wide standard protocol to validate the CCPs and preventive control measures in HACCP and food safety plans covering a wide range of food products. The document aims to eliminate or reduce the variation issues that can occur among food safety professionals, consultants, and third-party laboratories when validation studies are conducted Both the process and product design determine pathogen inactivation efficacy. Validation studies are specific for a given process and product, and should not be extrapolated to other products or processes with different characteristics
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