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Food Validation Protocols

We help you validate that your food processing protocols are accurate and can be reproduced. We help you develop the written documentation describing your protocols as required to meet applicable law and regulation. We know these laws and the conditions required to meet them.

Generally, every manufacturer must prepare a written validation protocol which specifies the procedures (and tests) that are conducted and the data collected. The purpose for which data are collected must be clear, the data must reflect facts and be collected carefully and accurately. The protocol should specify a sufficient number of replicate process runs to demonstrate reproducibility and provide an accurate measure of variability among successive runs.

The test conditions for these runs should encompass upper and lower processing limits and circumstances, including those within standard operating procedures, which pose the greatest chance of process or product failure compared to ideal conditions; such conditions have become widely known as "worst case" conditions. (They are sometimes called "most appropriate challenge" conditions.) Validation documentation should include evidence of the suitability of materials and the performance and reliability of equipment and systems.

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