FRAUNHOFER IZI RECEIVES GMP AND GLP CERTIFICATES
After a successful GMP acceptance inspection by the competent supervisory agency, the GMP operating site of the Fraunhofer Institute for Cell Therapy and Immunology IZI got the manufacturing approval pursuant to section 13 of the German Pharmaceuticals Act (Arzneimittelgesetz) for the manufacture and quality control of autogenetic (body’s own) bone marrow stem cells. The license extends to the manufacture of clinical investigational products for future clinical studies and includes the license pursuant to section 20b, subsection 2 on laboratory studies required for winning tissue.
In addition, Fraunhofer IZI officially received the GLP (Gute Laborpraxis) certificate for test category 9 with the specification „Immuntoxikologische Prüfungen in vitro“ (immunotoxological in-vitro tests). The successful initial inspection by the Saxon State Ministry of the Environment and Agriculture (Sächsisches Staatsministerium für Umwelt und Landwirtschaft) as the competent licensing agency had already been performed on August 3 – 4 of this year. This way, Fraunhofer IZI is able to implement the latest requirements of EMEA (European Medicines Agency) as the R&D service provision for developers of the latest medicines.
more information (manufacturing license)
more information (GLP certificate)