Studys / QMS / 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.
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
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"
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
* 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
* Process validation
* Encoding of all files / datafiles in one filing system
* Company's computer network by inclusion of QMS requirements