GMP-Compliance audit

The ATMP GMP audit team of the Valicare GmbH executed a GMP compliance audit from 5-6th of July at a potential contractual partner of an internationally working pharmaceutical company. The manufacturing of an advanced therapy medicinal product (ATMP) was proved on GMP compliance to formulate the frame conditions for the quality agreement and the requirements for the product. Initial application of the ATMP is planned under hospital exemption regarding §4b of the german drug law and shall be followed by a central european marketing authorization in the near future.