The GMP guideline finds its legal basis in Article 3 (2) of the European Directive 2003/94/EC in conjunction with Article 3 (2) of the European Directive 2003/94/EC. Article 47 (2) of European Directive 2001/83/EC. When granting a manufacturing licence, it is essentially checked whether all steps of production and testing are carried out in accordance with the principles of Good Manufacturing Practice (GMP).
The approval now entitles QSI to the chemical-physical quality control of herbal medicinal products for human use.
Quality control is the part of good manufacturing practice that deals with sampling, specifications and tests, as well as organizational, documentation and approval procedures to ensure that the necessary and relevant tests are actually carried out and that both the materials required and the products manufactured are not released for sale or delivery until their quality has been assessed as satisfactory.
For further analysis there is a cooperation with the BAV Institut (microbiology) and BLS Analytik (heavy metals).
Tentamus Group GmbH
An der Industriebahn 26
13088 Berlin
Telefon: +49 (30) 206038-230
Telefax: +49 (30) 206038-190
http://www.tentamus.com
QSI GmbH
Telefon: +49 421 596 60 70
E-Mail: arne.duebecke@qsi-q3.de