Microbiology Method
Development and Validation

Microbiology Method development is a process that involves designing, developing, validating and improving test methods for the purpose of analyzing microorganisms.

These methods can be used to determine whether a sample contains a specific type of microorganism, whether that organism is present in an appropriate concentration in the sample, or if the sample contains sufficient amounts of that particular species.

The steps involved in developing an assay include:

• Identifying the problem or objective that needs to be addressed.

• Collecting data on how samples were obtained and processed.

• Evaluating data to determine if it is accurate enough to be considered valid.

Once the assay has been validated it may be used as part of a quality control program to ensure that all tests performed using it are consistent with expectations based on its design parameters.