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8.6 - Laboratory Controls - Microbiology Testing manufacturing operations or group of containers

SKU: 11325561416

4.3
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Description

or group of containers

processing

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

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

8.6 - Laboratory Controls - Microbiology Testing manufacturing operations or group of containersMicrobiological 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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