GMP (Good Manufacturing Practice) are regulations for quality control during the production of pharmaceuticals, agents and medical products.  

Quality control plays an important role in the production of pharmaceuticals, as any deviations could have a direct effect on consumer health. A GMP-suitable quality management system guarantees the quality of the product and fulfils the binding requirements of the health authorities during production and distribution.   

Therefore, the GMP regulations have to be met by all producers of pharmaceuticals. This is regularly checked by the according local authorities. Both eticur) and also the stem cell bank of the University Hospital Erlangen fulfil these regulations.

According to the transfusion law in Germany, the regulations for blood products and their collection are stipulated by the German Medical Association. In November 2005, this association has tightened the regulations for autologous (own) stem cells from umbilical cord-/placenta blood as follows:  

"As far as the organisation, production and storage of autologous stem cells from umbilical cord-/ placenta blood are concerned, basically the according regulations for allogenic products apply". 

eticur) in cooperation with the stem cell bank of the University Hospital Erlangen is the only company that routinely fulfils these very high quality requirements of the German Medical Association: The regulations for allogenic (not own) umbilical cord blood stem cells are also applied to autologous storage. As the criteria which has to be fulfilled for general public, should also apply for your own child. 

The collection, processing and testing of umbilical cord blood stem cells falls under the German pharmaceutical law. A collection requires the existence of a manufacturing licence according to § 13 AMG. 

eticur) has this manufacturing licence, issued by the government of Upper Bavaria. In Germany, nearly 600 birth centres have been certified by eticur) and added to this manufacturing licence so far. It is a legal precondition that the individual birth centres are certified and added before collecting umbilical cord blood   

The procession and storage of the umbilical cord blood takes place in the stem cell bank of the University Hospital Erlangen. Their manufacturing licence was issued by the government of Central Franconia.

Processing stem cell materials does not yet authorise the provider to deliver if needed, especially to donate it to a third party. The authorisation for handing out the material is also limited by strictest regulations and is issued by the according supreme Federal authority, the Paul-Ehrlich-Institute (PEI). 

The public-private stem cell bank of the transfusion medical and haemostaseologic department of the University Hospital Erlangen, one of the leading institutions on the field of blood testing and blood processing in Germany and the largest centre for umbilical cord blood in Bavaria, was one of the first three institutions in Germany which obtained this authorisation.

• Separation
• HLA-Typification
• Direct pathogen check
• Freezing simulation
• Viability test with cell culture
• Storage in two separate tanks