Factsheet – DANGEROUS CONFIDENCE IN “GOOD LABORATORY PRACTICE”

Factsheet - DANGEROUS CONFIDENCE IN “GOOD LABORATORY PRACTICE”

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  • Dateigrösse 3.42 MB
  • Erstellungsdatum 11. Februar 2020
  • Zuletzt aktualisiert 11. Februar 2020
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PANGermany_Dangerous Confidence in GLP_2020_EN.pdfDownload 

Our authorisation system for chemicals is based on the principle that manufacturers must prove, by means of scientifc studies, that their products do not pose unacceptable risks to public health and the environment. It is therefore also the responsibility of manufacturers to
commission certifed contract laboratories to carry out the toxicological studies necessary for the approval procedure. As a guarantee against manipulation and falsifcation of these "regulatory" studies, regulatory authorities worldwide rely on the certifed standard of "Good
Laboratory Practice" (GLP). This standard provides for strict documentation requirements and regular internal and external controls. However, the current fraud scandal involving a German contract laboratory certifed according to GLP, shows that this trust is unlikely to be justifed. According to reports, GLP studies have been manipulated and falsifed there since 2005.