Process Validation

FSMA proposed rule language: the collection and evaluation of scientific and technical information to determine whether the food safety plan, when properly implemented, will effectively control identified hazards.

  • Comprehensive review of current setup and methods
  • Validation comes from a combination of reviewing scientific literature, mathematical modeling, regulatory recommendations/resourcing, and in-house challenge studies.
  • Validation can be done on existing process or prior to implementing a new method or process
  • A validation report will be provided at conclusion which includes background info, general info on the product and process, equipment and methods, results and a detailed discussion section.