What GMP rules and standards are relevant for pharmacy operations with their own production? What are the differences in the GMP requirements for a production license for small versus large quantities? What are all the things needed to obtain a wholesale license? And when does Swissmedic come into play?
These and many other open questions can quickly lead to uncertainty for pharmacy operations – especially with the amendment of the Swiss Therapeutic Products Act (HMG) that comes into force in 2019.
Aside from certain changes in the HMG, the dynamic further development of GMP regulations and guidelines also constitutes a challenge for many Swiss pharmacy operations. These are not a fixed construct, neither at the canton nor federal level, and are subject to constant change. Amendments, corrections, enhancements – maintaining an overview is far from easy. However, up to date expert knowledge is essential in such a sensitive environment in particular.
GMP and Pharmacies tells you how the GMP experts at gempex can assist pharmacy operations, and why the GMP service provide with its branch in Sisseln is their partner of choice.