Overview of USP 1223 and EP 5.1.6- Validation of Alternative Microbiological Methods
USP Chapter < 1223 > Validation of Alternative Microbiological Methods and EP Chapter 5.1.6 Alternative Methods for Control of Microbiological Quality provide guidance on the selection and implementation of assay methodologies to serve as alternatives to compendial microbiological methods. The documents describe important steps that should be taken to evaluate candidate alternative methods, to select the analytical technology and ultimately to qualify the method with actual product. These steps include, but are not limited to:
- Identification of a potentially suitable alternative methodology
- Demonstration that the method is equivalent and applicable as a replacement for a standard compendial method
- Development of user specifications for equipment selection
- Qualification of the method in the laboratory
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