Validation of an Automated Microbiology Method in the Age of Diverging Guidance 


Validation of an Automated Alternative Microbiology Method in the Age of Diverging Guidance

The European Pharmacoepia (EP) 9.2 Chapter 5.1.6 on alternative methods includes a clear structure for primary validation and validation of intended use, with directives for validation process for both technology supplier and the end user. This EP chapter has discrepancies with the US chapter <1223>.


This poster presented by technical experts at Rapid Micro Biosystems illustrates a validation study for Growth Direct System. Data generated from this study indicates the colony counting method of Growth Direct complies with assay performance requirements in EP Chapter 5.1.6 and USP Ch <1223>..


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