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.

Certificates

ISO certificate 9001_2015

ISO certificate 14001_2015

IQONet certificate ISO 9001_2015


GMP-certificate

 

                                                                          

Certificates of analysis

Online retrieval of current certificates of analysis

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CE label

not applicable

Our products and their production are ISO 9001 certified. They have no CE label as they cannot be related to any of the regulations stipulated by the German Act on Medical Devices (MPG).

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