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TICEBA GmbH receives permission after � 20c AMG for their quality assurance system

TICEBA GmbH erhält Erlaubnis nach § 20c AMG für ihr Qualitätssicherungssystem
TICEBA GmbH erhält Erlaubnis nach § 20c AMG für ihr Qualitätssicherungssystem
The TICEBA GmbH received permission after � 20c of the drug law (AMG) from the district administration Baden-Wuerttemberg. The TICEBA GmbH from Heidelberg in an isolated manner in a particularly developed procedure skin cells from Hautbiopsien and stores these over from it later, therein the contained� adulten main cells too� isolate. These are to stand in the future for new, singular therapy beginnings for order, for example with that� Treatment of autoimmune illnesses and degenerative illnesses such as disease Parkinson or diabetes Mellitus.Nach the changes at the drug law by the fabric law is now necessary for this production a permission after � 20c. The request for this permission was placed Baden-Wuerttemberg, on the basis of a quality assurance system, with the district administration T5ubingen, which was cut the regulatorische basis given by gempex the GmbH particularly to. After� that� AMWHV must fabric mechanisms, among which the TICEBA GmbH ranks, a quality assurance system after the defaults of the good ones technical practice (GFP) furnish. In addition all quality relevant processes in written instructions for procedure must be described. The suitability of the areas and equipment is to be shown in the context of the qualification and the manufacturing processes is to be validated. With these tasks the TICEBA GmbH received competent operational support by a team of experienced engineers and scientists gempex of the GmbH. The company, with seat in Mannheim, is specialized on the implementation from quality assurance systems to GFP and GMP (� property manufacture practice � for active substances and drugs). In addition it stood in all questions to the GFP � for Compliance � advisory to side photo: TICEBA

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