© 2010 Profil Institut für Stoffwechselforschung GmbH • Hellersberggstrasse 9 • 41460 Neuss • Germany
Pharmacy
Profil is a manufacturing authorisation holder according to § 13 German Drug Law (AMG) for Investigational Medicinal Products (IMP) including sterile dosage forms.
The GMP area of Profil provides a grade B clean room with LAF (laminar air flow) (grade A). The clean room is equipped with an airborne particle counter and microbial air sampler enabling the monitoring of regulations according to GMP guideline "Manufacture of Sterile Medicinal Products” (Annex 1).
Facts and Figures
- Certified for manufacturing of Investigational Medicinal products (IMP) according to GMP
- License for importation of non marketed and marketed pharmaceuticals used in clinical trials acc. § 72 AMG
- Reconstitution, dilution and pH adjustment under aseptic conditions for s.c. and i.v. injection and oral application
- Preparation of blinded IMP
- Storage of IMP under controlled conditions
- Labelling and handling of bulk ware
- Destruction of IMP
- All services controlled by a qualified person
Certificate of GMP Compliance
GMP-Zertifikat_10032010.pdf