Quality Control and Calibration, Quality Control and
Standard:Reference substances used for identification, inspection, and content determination, and reference substances used for the determination of content or potency in bioassays, antibiotics, or biochemical drugs, in terms of potency units or (ug)International standardsCalibration. (From the 2010 edition of the Chinese Pharmacopoeia)
Reference substance:Refers to the reference materials used for identification, inspection, and content determination, and unless otherwise specified, are used after calculation as dry products (or anhydrous substances). (Excerpted from the 2010 edition of the Chinese Pharmacopoeia)
Calibrators: namely, calibrators, having reference materials used as independent variable values in the calibration function; should have fixed values and known measurement uncertainties, the purpose of which should be to calibrate a measurement system, so as to establish the measurement results of this system Metrological traceability. (Extracted from GB/T 21425-2008, "In Vitro Diagnostic Reagent Calibrators (Objects), Quality Control Substances (Objects) Research Technical Guidelines")
Quality Control:Quality control substances (fixed and non-fixed values) for in vitro diagnostics, are substances, materials, articles or equipment intended for use in detection systems for medical purposes, the purpose of which is to evaluate or verify performance characteristics such as measurement precision, measurement accuracy, analytical bias that may occur in detection systems due to changes in reagents or analytical instruments. Quality control substances (fixed and non-fixed values), which can be used for capability verification, quality control in laboratories. (Extracted from "In Vitro Diagnostic Reagent Calibrators (Objects), Quality Control Substances (Objects) Research Technical Guidelines")
Fixed value quality control products:The fixed-value quality control has the manufacturer's reference value using the appropriate analytical method or process analysis, and specifies the reference range.
Non-fixed value quality control products:Non-fixed-value quality control products can be labeled with the target concentration (e.g. low, high, medium), but there is no specified reference range, and the analysis and testing system used for non-fixed-value quality control products cannot be specified, but the system rules for quality control must be met.
Reference:A material or substance having one or more sufficiently uniform and well-defined properties to calibrate a measuring device, rating a measuring method, or assigning a value to a material. (Excerpted from GB/T 21425-2008)
