Quality management at Biochrom GmbH
Biochrom GmbH's quality management system is certified according to DIN EN ISO 9001:2015. Internal and external audits, as well as numerous customer audits, ensure constant control and allow for continuous improvement of our quality management system.
Biochrom GmbH also holds a Manufacturer's Authorisation according to section 13 of the German Drug Law (AMG, Arzneimittelgesetz), authorising the aseptical production of large volume solutions for the storage of organs, tissue or cells.
We manufacture and aseptically fill our sterile products in qualified clean rooms (in accordance with appendix 1 of the EU GMP guide). A lot-related certificate of analysis includes all results obtained in the final quality control tests.