GLP-Certification

tl_files/spectralservice_design/images/Logos und Symbole/glp_th.JPGSince 16th December 1992, Spectral Service has held the Certificate for working in compliance with "Principles of Good Laboratory Practice (GLP, §19a ChemGes)" of the Ministry Labour, Integration and Social Affairs of Nordrhein-Westfalen, Germany. File reference III 5-31.11.32.06.

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Field of application:

Category 1: "Tests on physico-chemical properties and quantifications"

Inspections:

  • December 16, 1992
  • July 18, 1995
  • October 19, 1999
  • November 19, 2003
  • February 8, 2008
  • June 6, 2012
  • August 26, 2015

GMP-Certification

tl_files/spectralservice_design/images/Logos und Symbole/gmp_th.JPGSpectral Service is in substantial compliance with the requirements of the AMG §14 and EC Good Manufacturing Practices of Medicinal Products regarding the listed testing procedures. File reference CGN24.30.12-P-/01/2015/027

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Field of application:

Physical and physicochemical methods (pH, Absorption spectrophotometry infrared, Absorption spectro-photometry ultraviolet and visible, Gas chromatography, Liquid chromatography, Nuclear magnetic resonance spectrometry, Mass spectrometry), Differential scanning caliometry, Assays (Water: semi-micro determination)

Inspections:

  • September 2, 2004
  • February 8, 2008
  • October 29, 2009
  • October 1, 2012
  • January 28, 2015

FDA-Audited

In October 2010 and September 2014 (No Findings!), Spectral Service was audited by the US Food and Drug Administration (FDA), FEI-Nr. 3008542737. The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments.