| http://www.w3.org/ns/prov#value | - A critical factor is defined by the U.S. Food and Drug Administration (in 21 CFR 113.3) as any property, characteristic, condition, aspect or other parameter, a variation of which may affect the scheduled process and the attainment of commercial sterility.[1] The ???scheduled process??? means the process selected by the processor as adequate under the conditions of manufacture for a given product
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