Certification

GLP-Certification

Since 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 of Environment and Agriculture of Nordrhein-Westfalen, Germany. File reference IV C4-31.12.32

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Field of application:

"Characterisation of Test- and Reference Material with Spectroscopic Methods (e.g. NMR, MS, IR, GC, HPLC) with Respect to Content, Identity and Purity."

Inspections:

• December 16, 1992
• July 18, 1995
• October 19, 1999
• November 19, 2003
• February 8, 2008 (valid until 2012)

Certificate for Category 1:

"Tests on physico-chemical properties and quantifications"

Spectral Service is registered at District Authority Cologne as Laboratory for pharmaceutical analyses (§64 AMG)

GMP-Certification

Spectral Service is in substantial compliance with the requirements of the EC Good Manufacturing Practices of Medicinal Products (sect. 14 para 4) regarding the listed testing procedures. File reference 24.30.12-P-/01

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Field of application:

Physical and physicochemical methods (pH, Absorpotion spectrophotometry infrared, Absorpotion spectrophotometry ultraviolet and visible, Gas chromatography, Liquid chromatography, Nuclear magnetic resonance spectrometry, Mass spectrometry), Pharmacetical technical procedures (Pycnometric density of solids), Differential scanning caliometry

Inspections:

• September 2, 2004
• February 8, 2008
• October 29, 2009

FDA-Audited

In October 2010, 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.