Kalibrier- und Prüfmittelmanagement
gempex GmbH, Mannheim
Korrespondenz: Wolfgang Hähnel, gempex GmbH, Besselstr. 6, 68219 Mannheim (Germany), e-mail: firstname.lastname@example.org
Management of Calibration and Measuring Systems
Calibration is an important component of quality assurance in the technical area of a pharmaceutical company and is mandatory in the corresponding GMP regulations. When ordered to calibrate the quality critical measuring systems, service providers as well as calibration laboratories or in-house departments, should be audited for their suitability in advance. Supervision/Control of execution and verification of documentation are especially important where calibration activities are concerned. When selecting a potential calibration service provider it is essential that they have been accredited according to DIN EN ISO 17025, or at the minimum have a quality assurance system. Only these suppliers are qualified to do high-quality calibration. The fundament of all calibration activities is the accuracy of the reference measuring systems together with adequately trained personnel.
Key words Akkreditierung • Eichung • Justage • Kalibrierung • Kontrolle • Messeinrichtungen • Wartung/ Instandhaltung • Zertifizierung