Validation of Microbial Reduction Processes for Spices
The Validation of Microbial Reduction Processes for Spices white paper provides information on validating microbial reduction techniques. It includes an executive summary (the 6 phases of validation), introduction, approaches to validation, validation processes, and information on validation protocols and studies.
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Related Resources
Webinar on ASTA Guidance on Science-Based Groupings to Optimize Validation of Spice Process Controls
Under the Preventive Controls for Human Food regulation, manufacturers of ready-to-eat spices must have validated process controls to ensure that Salmonella and other known pathogens are effectively controlled. Since it is typically resource-prohibitive and redundant to run a validation study on every single product produced by a spice company, ASTA has assisted its members in developing a science-based approach to validation that involves conducting a study on a representative product of a group of spices, rather than every different commodity. The updated ASTA Guidance on Science-Based Groupings and Report on Microbial Inhibition of E. Faecium, along with this webinar, will provide an update on the ASTA guidance and scientific evidence regarding validation for spices. The presenters, Jim Dickson, Iowa State University and Maile Hermida, Hogan Lovells, and ASTA General Counsel, explore the latest scientific evidence on key factors for selecting a representative “worse case” scenario for groupings and the impact of microbial inhabitation on validations. The webinar included a review of the regulatory requirements related to validation and an overview of the ASTA resources that have been developed on this topic. ASTA previously offered the ASTA Webinar Series on Validation of Microbial Reduction Processes and published a White Paper on Process Validation. During ASTA Online in 2020, the FDA presented Validation Information for Spice Companies. Then, during ASTA Online 2021, there was a Panel Discussion on Science-Based Groupings for Spice Validations. Registrants of this webinar will get access to all of these resources in advance of the session.
Guidance on Science-Based Groupings to Optimize Validation of Spice Process Controls
This document, revised in May 2022, provides guidance on science-based groupings to optimize the validation of spice process controls. It includes considerations for validation, considerations for process validations based on groupings, examples of validations of spice groupings, etc.