ISAR Bioscience receives manufacturing authorisation and GMP Certificate
Planegg, 15 December 2023 - ISAR Bioscience has been granted a manufacturing authorisation in accordance with the German Medicines Act (§13 AMG) and a GMP (Good Manufacturing Practice) certification for its facility in Planegg near Munich. The internationally recognized certification ensures the high quality of investigational medicinal products over the entire manufacturing process, in accordance with the current European Clinical trials Regulation No 536/2014 and with European GMP guidelines as well as with those of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
The GMP certificate granted by the regulatory authority allows ISAR Bioscience to manufacture the investigational medicinal products for clinical trials with immediate effect and to have them released by the Qualified Person Suzana Levacic-Schulz. GMP and manufacturing standards are independently monitored and inspected by the pharmaceutical authorities.
This certificate is an extraordinary milestone in the ISAR Bioscience’s history. The way is now clear for the first clinical trials. With the GMP certification, ISAR Bioscience can manufacture its own investigational medicinal products and test them for efficacy in clinical trials.