To ensure patient safety, InnoMedica places great importance on a well-functioning quality system. InnoMedica's quality management system is based on the requirements of Good Manufacturing Practice (GMP) and has been certified by Swissmedic.
All new employees of InnoMedica undergo internal GMP training. Quality awareness is specifically anchored in a wide range of work steps and the awareness of potential problems is promoted from the very start, while internal quality processes are explained at the same time.
InnoMedica's quality control in accordance with GMP requirements begins before the products are manufactured with the qualification of the devices and the testing of incoming raw materials. Each batch produced is analyzed several times by the quality control and analytics department: Samples are taken and checked during the manufacturing process, at the end of production and during storage. The quality assurance team then checks the GMP documents and releases the batches for use in the clinic. Under controlled conditions, the final filled vials with the medication are ultimately delivered to the various clinical trial sites and treatment centers in Switzerland.
The quality system of InnoMedica was expanded with the assumption of the role as sponsor in the conduct of clinical trials by gradually implementing the requirements of Good Clinical Practice (GCP). These guidelines ensure the protection of patients in clinical trials. Closing the interface between GMP and GCP brings decisive advantages for the quality system and makes InnoMedica independent with regard to the conduct of trials.
