Both the Food and Drug Administration (FDA) and the Food Safety Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) require that food processes used to control potential public health hazards be validated. The process of validation is the establishment of objective scientific evidence that the process is adequate to prevent, reduce, or eliminate potential public health hazards from the product.
Where product safety cannot be fully verified by meeting a set standard (i.e., milk pasteurization), the process must be validated according to established procedures. When any of the conditions listed below exist, process validation is the only practical means for assuring that processes will consistently produce products that meet their predetermined specifications:
When conducting a validation study, it is important to have appropriate facilities, knowledgeable experts, and recognized protocols. Validation studies can be complicated and are usually costly. IEH has extensive experience and understanding on how to carefully plan and complete a validation study, which includes:
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