8.6 - Laboratory Controls - Microbiology Testing manufacturing operations The definitions and interpretations of

The definitions and interpretations of terms in section 201 of the Federal Food

and any other contact surfaces used to manufacture

That lot may only be retested and released if the investigation clearly determines a laboratory error in the original result

You must establish a specification for identity

SOP for determining the TYMC

8.6 - Laboratory Controls - Microbiology Testing manufacturing operations The definitions and interpretations ofMicrobiological pharmacopeia methods are considered to have been validated however the performance criteria and the suitability for each product type must be verified. Quantitative test methods must be validated by determining in assays the sensitivity, repeatability, reproducibility and the limit of quantification within a defined variability