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by Quality Control according to USP <1217> and EP 2
and workmanship to enable them to be suitable for their intended use and to be adequately cleaned and properly maintained thus preventing cross-contamination
and any other contact surfaces used to manufacture
processing
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
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