This paper provides case studies and best practice guidance for validation of an alternative mycoplasma detection assay. It includes an example of completing a user requirement specification (URS) for evaluating an alternative mycoplasma detection assay, validation and implementation. Strategies are also provided to help identify suitable technologies for defined applications. Finally, a framework is given to demonstrate how a validation protocol for an alternative mycoplasma detection assay can be executed to meet the regulatory expectation that the alternative method is equivalent to or better than the current compendial methods.
rapid microbiological methods
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