Certification

Responsible for compliance

GLP certified

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Spectral Service is certified since
16. December 1992 for its compliance with “Good Laboratory Practice (GLP)” according to § 19 ChemGes (German Chemical Law) and Directive 2004/9/EEC under reference A III 5-8673.32 by the Ministry for Work, Health and Social Aspects (MAGS NRW).

 

Area of Expertise:

category 1: “Physical-chemical testing”

Inspections:

  • 16. December 1992
  • 18. July 1995
  • 19. October 1999
  • 19. November 2003
  • 8. February 2008
  • 6. June 2012
  • 26. August 2015
  • 22./ 23. August 2018

GMP certified

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Spectral Service complies with the requirements for analytical quality testing according to AMG § 14 (German Drug Law) and EU GMP guideline for Good Manufacturing Practice (GMP), documented by certification under reference CGN/24.30.12-P/01/2018/043.

Area of Expertise:

2.2 Physical and physico-chemical tests

  • 2.2.3 Potentiometric determination of pH,
  • 2.2.5 relative density,
  • 2.2.24 Absorption spectrophotometry IR,
  • 2.2.25 Absorption spectrophotometry UV-VIS,
  • 2.2.28 Gas chromatography,
  • 2.2.29 Liquid chromatography,
  • 2.2.33 Nuclear Magnetic Resonance spectrometry,
  • 2.2.34 Thermoanalysis,
  • 2.2.43 Mass spectrometry

2.5 Assays

  • 2.5.12 Semi-micro determination of water – Karl-Fisher method,
  • 2.5.32 Micro determination of water – coulometric titration

Inspections:

  • 2. September 2004
  • 8. February 2008
  • 29. October 2009
  • 1. October 2012
  • 28. January 2015
  • 25. January 2018

 

FDA approved

Spectral Service has been successfully inspected in October 2010 and in September 2014 by the US Food and Drug Administration (FDA) under reference FEI-Nr. 3008542737. The US Food and Drug Administration (FDA) is the responsible agency for monitoring food and feed safety as well as for the regulation of prescription drugs within the Department of Health and Human Services.

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