8.6 - Laboratory Controls - Microbiology Testing manufacturing operations by Quality Control according to

by Quality Control according to USP <1217> and EP 2

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

processing

SOP for determining the TYMC

8.6 - Laboratory Controls - Microbiology Testing manufacturing operations by Quality Control according toMicrobiological 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