It was an enormous success that the API manufactures have received their own GMP guideline by ICH because there are significant differences between the GMP requirements for Drug (Medicinal) Products and APIs.
This course will provide practical guidance of key aspects laid down in the ICH Q7 guideline. It will clarify and layout the appropriate GMP standard to be applied by API manufacturers. In particular it will address GMP related topics of quality, production, logistic, engineering and biotechnology.
It is a unique chance to receive first-hand knowledge, interpretation and understanding of ICH Q7 and to ask questions to one of the ICH Q7 authors.