Developing a quality control program for advanced therapy medicinal products in Europe

Advanced therapy medicinal products (ATMP) are complex medicines based on gene therapy, somatic cell therapy, and tissue engineering. These products are arising as novel and promising therapies for a wide range of different clinical applications. The quality control system, which operates independent from production, is a key element during manufacturing and ensures that the finished product obtained has been produced with the quality and safety required. Control strategy includes the sampling plan, test methods and acceptance/rejection criteria for raw and starting materials, intermediates and finished products. Furthermore, it has an important role in stability testing and microbiology monitoring of production areas, equipment and personnel. The quality control system has implemented quality management tools such as risk-based approach and change control programme in their working routine. However, some other quality control aspects like availability of ATMP reference materials or proficiency testing to ensure the reliability of the ATMPs analytical measurements still remain under development.

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