Microbial assay is one of the basic components of drug safety, which is of great significance in both theoretical research and production practice. Due to the variability of the microbial assay itself, such as sampling error, dilution error, operating error, culture error and counting error in the microbial assay method, as well as the uneven distribution of microorganisms in the test sample, microbial assay method development and method validation is more complicated than that of the physical and chemical method development and method validation.
