Get the Sherpa guide on EU GDP Guidelines.It is up to pharmaceutical companies sponsoring clinical trials in the EU to have comprehensive control of their supply chain. This ensures the quality of their drug supply is not compromised and patients are not inadvertently administered counterfeit or falsified drugs. The intent of the original EU GDP Guidelines as additional details in some existing ones, such as qualification and validation, risk management, and quality management. Many sections within it now align more closely with GMP expectations. The new guidelines also offer more comprehensive guidance for temperature management during
storage and transportation.
Sponsor companies should have a particular focus on these three areas:
- Quality systems
- Computerized systems