Our own GMP laboratory
The company's own GMP laboratory is certified
by the TÜV Süd according to EN ISO 14644.
German Centre for Cell Therapy has its own state-of-the-art, 150m² laboratory for the aseptic production of parenteral preparations, that meets the highest possible international quality guidelines, so called GMP standard.
GMP stands for "Good Manufacturing Practice". This standard is defined by highest possible quality requirements for production processes, production environment, quality assurance and documentation in pharmaceutical manufacture. This ensures the greatest possible degree of safety for the patient.
Compliance with GMP standards is controlled by recurring inspections by the state authorities as well as regular tests of technical equipment by independent companies including TÜV Süd and certified according to EN ISO 14644.
Clean room areas of the laboratory are divided into classes A, B, C and D, with requirements for each class being defined by the GMP guidelines. Accordingly, each class is regularly checked for microbiological contamination and air purity.
Entering the laboratory area is only allowed with special clothing. Access to the production area (clean room class B) is also via several airlocks, in which a sterile overall including hood, face mask and overshoes, as well as two layers of sterile gloves must be worn. The production of preparations takes place solely within sterile Laminar Air Flow Workbenches in the production area (clean room class A in B).
The entire laboratory area is equipped with a complete monitoring system that monitors the essential parameters at all times and sounds the alarm in case of non-compliance.
The physicians of the German Center for Cell Therapy manufacture the preparations individually for the patient depending on the therapy situation. The manufacturing process is carried out in compliance with the GMP criteria according to the specifications of the German Drug Law §13 Abs. 2 b. The attending physician is supported during the manufacturing process by experienced and qualified specialists who are familiar with the latest technology and hygiene requirements through training.
Every production is accompanied by the internal quality assurance and examined by external laboratories in order to provide an absolutely safe preparation for the patient.