From Good Manufacturing Practice (GMP) to Good Clinical Practice (GCP)
In November and December, the EKFZ Academy hosted two workshops dealing with the regulations and guidelines for the safe, effective and high-quality manufacture and testing of medicinal products.
Dr. Sabine Hauck addressed the GMP standards for the manufacture of Advanced Therapy Medicinal Products (ATMPs) and guided the audience through the requirements for GMP documentation. Based on her broad expertise in the life science industry, she also provided valuable insights into the interaction with contract manufacturers and highlighted the interface to GCP.
Complementing this excellent workshop, Dr. Ralph Telgmann and Dr. Thomas Asendorf from the Clinical Trials Unit at Universitätsmedizin Göttingen gave a comprehensive overview of the requirements for clinical trials. They discussed the classification of different types of trials, their regulatory differences, as well as statistical aspects of case number planning, power calculation, and endpoint determination. During a guided tour through the Early Clinical Trial Unit (ECTU) of the Fraunhofer Institute for Translational Medicine and Pharmacology ITMP headed by Prof. Martin Weber, Dr. Christiane Weinrich and Krishya Sritharen showcased how early phase I/ II clinical trials are planned and implemented in a state-of-the-art environment.
The key takeaways from the workshops were:
• Fundamental rule of GMP: if it is not documented, it was not done
• Tech transfer from research & development to GMP needs a lot of preparation, effort and time
• A clear definition of the investigated study object is crucial for the applicable regulations and the effort involved
• Don’t overload your clinical trial(s)
We sincerely thank all speakers for their excellent and informative presentations as well as the Fraunhofer Institute for Translational Medicine and Pharmacology ITMP for providing inspiring insights into the ECTU!
