Audits of biotechnological APIs

Blue conducts GMP API audits of conventional fermentation as well as of biotechnology / bioengineering (and biological) manufacturing processes of active ingredients.

Biotech APIs

The manufacture of active ingredients of human, animal, microbial or genetically engineered/modified origin by fermentation, cell culture or biological techniques, and the subsequent purification processes are usually more complex than those associated with conventional chemical synthesis. In addition to the general requirements of part 2 of EU GMP (ICH Q7) with a special Chapter 18 ( “APIs manufactured by cell culture/fermentation“), further requirements such as those stipulated in EU GMP Part 1 Annex 2 ("Manufacture of Biological Medical Products for Human Use") must be considered with respect to viral safety and aseptic working conditions, especially when it comes to biotechnology active ingredients.


Blue Inspection Body GmbH
Am Mittelhafen 56
48155 Muenster, Germany
Phone: +49 251 9759950-100