blue – ISO 17020 (type A) accredited inspection body for API GMP audits

Audits of herbal APIs

GMP API auditing of the manufacture of herbal active ingredients necessitates extensive professional know-how and experience in plant cultivation and plant collection, the initial processing steps on the fields and storage, as well as sound familiarity with industrial extraction. blue conducts these audits not only for GACP (Good Agricultural and Collecting Practice) purposes, but also for herbal active ingredients.

Herbal active ingredients

The manufacture of active ingredients from herbal starting materials by extraction and occasionally by semi-synthetic modification is an exception to the rule in the manufacture of active ingredients. Starting materials of natural origin are subject to a significantly greater variability and often also instability than chemical starting substances. In addition, large amounts of various solvents and special separation techniques are often required in order to isolate the desired substances.


blue inspection body GmbH
Hafenweg 18-20
48155 Muenster, Germany
Phone: +49 251 9759950-100

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