Quality Management

The handling of human cells requires extreme diligence and the compliance with the highest safety standards. Due to our successful quality management, we are able to meet these requirements.

Medicines Act

First and foremost, our product back up is subject to the Medicines Act. We hold the authorisation for the manufacturing of tissue as source material of human origin for the manufacturing of pharmaceuticals in accordance with § 20b and § 20c of the German Medicines Act (AMG): Authorization for the treatment or processing, preservation, storage of tissue or tissue preparations. The application for the extension of the manufacturing license in accordance with § 20b and § 20c AMG for the enrichment of mesenchyme pluripotent stem cells out of autologous primary cell cultures has been submitted to the competent authorities at the end of July 2011.

Good Practice

Due to the high significance of "Good Practice" at SMC, this issue of quality management is contemplated separately.

Quality Assurance System

Tissue institutions are obligated by law and other requirements to set up a quality assurance system (QA-system). It is supposed to contribute to the proper proceeding of any procedures in connection with the manufacturing of the products. The required quality is thereby to be assured. In addition, a QA-system contributes to reaching a higher level of security with regard to complex proceedings; to enable employees to act on their own responsibility within the framework of clear specifications and to increase the trust of patients and employees in the institution.

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