Good Manufacturing Practice (GMP)
Good Manufacturing Practice (GMP) is a system to ensure that medicinal products intended for human use are consistently produced and controlled according to appropriate quality standards. Swiss manufacturers of medicinal products must comply with international GMP standards set forth by the European Union (EU). These GMP standards are built on three pillars: 1) Pharmaceutical substances and products intended for human use are to be manufactured at sites that are adequately equipped, 2) the producer has to demonstrate appropriate professional and technical knowledge that is provided by qualified staff, and 3) a pharmaceutical Quality Assurance (QA) system needs to be established by the manufacturer.
The DBM has obtained a permit from Swissmedic in March 2015 to operate such a manufacturing laboratory. Headed by Werner Krenger, PhD, the “GMP core facility”is located on the 4th floor of the ZLF and offers as “Provider” central services to individual DBM research groups (“Users") that permit the manufacture of advanced investigational medicinal products (ATMP) to be used in clinical trials. A delimitation agreement between Provider and User regulates activities and responsibilities. The final product is released for clinical use by the head of the core facility who certifies product batches in his function of a "Qualified Person" (QP).
Affiliation and Staff
Both the core facility provider and the DBM research group users are required to contribute to the implementation of a fully functional QA-system necessary for the release of GMP-compliant medicinal products: The QA-team includes several positions of the core facility staff, including the QP (PD Dr. W. Krenger), the QP deputy (PD Dr. Paul Zajac), the QA manager Anke Wixmerten; and an external quality assurance consulting firm “Quality Assurance Consulting AG; QAC). Additional QA functions need to be provided be the research teams wishing to manufacture products in the facility team, including at minimum the Quality Control manager (QC), a Manufacturing Manager (MM) and a “Product Manager” (PM; who is usually the principal investigator of a research group). As a unit the QA-team establishes the relevant documentation required for implementation of an appropriate production process. Training of all staff (both core facility staff and research group staff) is organized by the core facility staff. Interested persons not currently affiliated with research groups working in the facility are also welcome to attend training sessions.
The GMP facility, including its supporting utilities (computerized GMP monitoringsystem and the laboratory instruments) are being routinely qualified and requalified in accordance with the requirements of GMP.
Since obtaining the operating license for the core facility, two DBM research groups have been using the GMP laboratory services to produce different ATMPs (cartilage tissue and genetically engineered vaccinia virus) to be used in clinical trials. The facility offers, however, the capacity for inclusion of additional teams upon their request. The DBM hopes that the availability of this core facility will further stimulate the transition of preclinical research into the study of exciting new investigational medicinal products.