Harmonized Microbial Limits Testing Validation Strategies

Obtaining successful validations of certain raw materials and finished products can be tricky. Researching the materials beforehand is important. By working closely with development scientists and chemists, setting appropriate specifications, and performing research, method development trials can be streamlined to produce an adequate method. Key factors in developing a proper method include some experimentation as well as knowledge of the pH of the material, the water activity of the material, the water solubility of the material, and any antimicrobial properties of the material, to name a few. Risk assessments can be used to determine what to test, how frequently to test, the stability program, and objectionable microorganism identification. Clear documentation and adequate scientifically sound justifications are necessary so that the any future questions can be easily answered.

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