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SOP for determining the TYMC
processing
That lot may only be retested and released if the investigation clearly determines a laboratory error in the original result
the lot and any other implicated lots must be quarantined and an out of specification (OOS) investigation conducted to determine the validity of the result
8.6 - Laboratory Controls - Microbiology Testing manufacturing operations SOP for determining the TYMCMicrobiological 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