Biomedical Engineering Reference
In-Depth Information
Guideline
Major topics
FDA GLP (21CFR58)
Ensures the quality and integrity of test data, personnel, facilities, articles, and documentation in pharmaceutical industry
EPA GLP (40CFR792)
Ensures the quality and integrity of test data, personnel, facilities, articles, and documentation in agriculture chemical
industry and environmental protection organizations
USP34-NF29 S1 <11>
General Requirements/ <11 > USP Reference Standards—definition and applications
ISO guides for reference materials
ISO Guide 30:1992/Amd 1:2008 Revision of definitions for reference material and certified reference material
ISO Guide 31:2000 Reference materials—Contents of certificates and labels
ISO Guide 32:1997 Calibration in analytical chemistry and use of certified reference materials
ISO Guide 33:2000 Uses of certified reference materials
ISO Guide 34:2009 General requirements for the competence of reference material producers
ISO Guide 35:2006 Reference materials—General and statistical principles for certification
USP34-NF29 S1 <1225>
Validation of compendial procedures
ICH Q2(1)
Validation of analytical procedures
IUPAC method validation
International Union of Pure and Applied Chemistry, Harmonized guidelines for single laboratory validation of method
of analysis
NIST Tech Note 1297
Guidelines for evaluating and expressing the uncertainty of NIST measurement results
ISO 15193—Bioanalytical
procedures
ISO 15193:2009 In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—
Requirements for content and presentation of reference measurement procedures
ISO 5725—Accuracy (trueness and
precision) of measurement
methods and results
ISO 5725-1:1994 General principles and definitions
ISO 5725-2:1994 Basic method for the determination of repeatability and reproducibility of a standard measurement
method
ISO 5725-3:1994 Intermediate measures of the precision of a standard measurement method
ISO 5725-4:1994 Basic methods for the determination of the trueness of a standard measurement method
ISO 5725-5:1998 Alternative methods for the determination of the precision of a standard measurement method
ISO 5725-6:1994 Use in practice of accuracy values
FDA bioanalytical method validation
Guidance for Industry, Bioanalytical Method Validation
NIST methods and Reference
Materials
Development of reference methods and reference materials for the determination of hormones in human serum
EPA
EPA Chemical QC Guidelines
EPA method 539: Determination of hormones in drinking water by solid phase extraction (SPE) and liquid chromatogra-
phy electrospray ionization tandem mass spectrometry (LC-MS/MS) [ 77 ]
 
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