This comprehensive course aims to show that even in a GMP environment, optimising costs can be achieved without neglecting compliance. Experts from the pharmaceutical industry and the authority with long practical experience have critically examined the current implementation of cGMP requirements. In the course, they will express their opinions on identifiable trends.
Besides, practical examples focused on quality assurance and technology will be presented:
From an authority perspective
With regard to efficient use of GMP
Modern Aspects of Process Optimisation
The implementation of the EU GMP Guide at the beginning of the nineties opened the door to GMP in Europe. In the USA though, the American GMP regulations CFR 210/211 have already been applicable since the sixties. In both regions, the new Compliance requirements have led to costs for the pharmaceutical industry. This trend is continuing. New GMP requirements such as the creation of a Product Quality Review for the EU area or FDA’s required “Continued Process Verification” have created new expenses.
In return, politics call for affordable medicinal products and at the same time increase cost pressures on pharmaceutical companies.