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.
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.