Compliance to national and international standards, traceability | 44070
Journal of Pharmaceutical Care & Health Systems

Journal of Pharmaceutical Care & Health Systems
Open Access

ISSN: 2376-0419

+44 1300 500008

Compliance to national and international standards, traceability and data integrity

11th World Congress on Pharmaceutical sciences

September 28-29, 2018 | Montreal, Canada

Jorg Bampfer

Anton Paar GmbH, Germany

Scientific Tracks Abstracts: J Pharma Care Health Sys

Abstract :

Data security, integrity and traceability play�??s an ever-increasing role for both, users and suppliers of analytical instrumentation. Today, this is particularly driven by pharmaceutical regulations, whose main aim is to make substances entering the human body as safe as possible. Also in food-, flavor- and fragrance applications traceability quickly gains importance. In polarimetry and refractometry, the foundation to quantitative analysis and common standards has been laid by sugar industry associations in close cooperation with national metrological institutes, primarily ICUMSA International Commission for Uniform Methods of Sugar Analysis, NIST National Institute of Standards and Technology, agency of U.S. Department of Commerce, Gaithersburg, USA and PTB Physikalisch-Technische Bundesanstalt, Braunschweig / Berlin, Germany. Calibration with a reference standard is only meaningful if the standard can be traced back to a national standard or normal, cf. VIM: Traceability is �??the property of the result of a measurement or the value of a standard whereby it can be related to stated references, usually national or international standards, through an unbroken chain of comparisons all having stated uncertainties.�?� Additionally, the instrument used for the analysis should offer more than only the required compliance, as still human errors during the instrument use, could have a major impact on the quality of the results and their traceability.

Biography :