Regulatory Affairs
The following registration activities are recently in process: Introduction of a quality management system according to EN ISO 9001. CE certification of capillary membrane bioreactors including pumping and control systems as a class III medical product.  The structuring of cell treatment under GMP conditions takes place in the area of clinical services.
 
CE Certification,
Quality Management System (QMS) and
GMP conditions - Good Manufacturing Practice
While considering quality from the point of view of the ISO caters to the producer/client relationship, the guidelines of the German pharmaceutical law (AMG) are designed for the safety of patients: patients are not supposed to be competent clients and an institutionalized authority guarantees the safety demands on their behalf. In this connection the official function may be considered as an external and additional quality assurance.
Hybrid Organs innovative clean room equipment combines closed systems and integrated isolator technology. It allows a scale-up industrial manufacturing of
individual cell-based therapeutics.
Hybrid Organs quality management system certified according to ISO 9001 integrates GMP criteria according to pharmaceutical law (AMG) and the requirements according to EN Certification.
The objective was to get the whole management system workable in reference of fulfilling the various interests of the enterprise's partners. So GMP conditions and QMS ISO 9001 could be realised in one system. This required  new decisions on titles of the QMS manual chapters and the renaming of procedures in SOP's and in production and control instructions as well as the introduction of the QMS manual chapters "validity/qualification" and "rooms".
All employees are participating in the QMS process in order to achieve a high acceptance and consequence in the QMS realisation. This shows advantages:
* In introducing the QMS, structures of the company's proceedings could be optimized and arranged in a more transparent way.
* The standardized recording system allowed to optimize the warranty of backtracking.
* Improved prevention measures to avoid errors and increase of efficiency in internal processes.

In the production of autologous keratinocyte transplant as a drug under current Good Manufacturing Practice this necessitates:
* Personnel qualification and training organized according to GMP as well as to QMS/CE
* Cleanroom and installation qualification
If processing of cells takes place under laminar airflow zones class A in B in C cleanrooms, air filtration and recycling are controlled
If processing cells in laminar airflow isolators with class A specifications in class C cleanrooms, air filtration/ recycling and overpressure with a cascade differential between a lock-chamber and the manufacturing areas are controlled.
* Process validation
* Encoding of all files / datafiles in one filing system
* Company's computer network by inclusion of QMS requirements