Traceability without uncertainty: current situation in the pharmaceutical industry

Traceability without uncertainty: current situation in the pharmaceutical industry

The current situation in the pharmaceutical industry is discussed, when the traceability of measurement (analytical) results to certified values of pharmacopoeial reference standards is required, without evaluating their uncertainties. It is shown that the evaluation of measurement uncertainty is ne...

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Veröffentlicht in:Accreditation and quality assurance 2003-11, Vol.8 (11), p.530-531
Hauptverfasser: Kuselman, Ilya, Weisman, Alexander, Wegscheider, Wolfhard
Format: Artikel
Sprache:eng
Schlagworte:
Laboratories
Pharmaceutical industry
Pharmaceuticals
Property values
Quality standards
Reference materials
Uncertainty
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Beschreibung
Zusammenfassung:The current situation in the pharmaceutical industry is discussed, when the traceability of measurement (analytical) results to certified values of pharmacopoeial reference standards is required, without evaluating their uncertainties. It is shown that the evaluation of measurement uncertainty is necessary for understanding the level of confidence of the analytical results and their comparability, particularly during preparation and characterisation of the reference standards.
ISSN:0949-1775
1432-0517
DOI:10.1007/s00769-003-0686-9