FIMEA fully reviewed Nanoform for compliance with its processes and adherence to GMP for the manufacture of multiple clinical active pharmaceutical ingredients (APIs)
Nanoform Finland has shed light on the results of a recent GMP inspection by FIMEA (Finnish Medicines Agency).
During the inspection on March 28th, 2023, FIMEA fully reviewed Nanoform for compliance with its processes and adherence to GMP for the manufacture of multiple clinical active pharmaceutical ingredients (APIs).
Nanoform received no critical or major observations during this inspection, which is a testimony to the importance Nanoform places on quality in everything it does and received by FIMEA a renewed license May 8th, 2023.
Following this renewed license Nanoform has now commenced GMP manufacture for nanoforming of a currently marketed blockbuster drug for a clinical trial planned in Q4 2023. Nanoform has also been audited by an independent European GMP auditor for this project and again received no critical or major observations.
The Finnish Medicines Agency Fimea is the national competent authority for regulating pharmaceuticals. As a central administrative agency operating under the Ministry of Social Affairs and Health it promotes the health and safety of the population by regulating medicinal, medical devices, blood and tissue products, biobanks and by developing the pharmaceuticals sector.