Contenuti:
Implementation of Directive 2011/62: what’s changed in APIs’ production and import :
- GMP and GDP: how API manufacturers may correctly approach the topics
- GMP compliance: European and extra-European landscape
- Biological substances: traceability and safety
- How select the API starting material: GMP and regulatory approaches
- From synthesis to bio-transformation: management of the quality and regulatory life of an API
- Borderline medical devices and combined products
Visualizza brochure e relazioni