Logistics plays a major role in supply chain of medicinal products. GDP rules, implemented in 2013 on EU level for finished products, and on all other regulated environments worldwide since years, still challenges logistic provider, contract giver, and contract acceptors. Any service provided has to be assessed, by an audit based on the EU GDP regulations.
Logistic is a service provided to any product in the world. The logistics for medicinal products need to follow the GDP regulations, either EU, or any other regulations in place. Third party service provider need to be qualified. One part of this qualification package is an audit checking the compliance to the GDP guidelines.
The challenge awaiting the auditor is to match the expectations of a highly regulated industry with the business understanding of (worldwide) acting logistic providers. Auditors need to prepare the audits, be up-to-date, trained, and have a high level of technical and social skills.
On October 28 and 29, 2020, a live online training "The GDP Audit" of the ECA Academy will be held. Dr. Martin Melzer, Principal Consultant at gempex, provides valuable input as main speaker with many years of experience in industry and government.
In case of any questions on GDP issues regarding pharmaceuticals, please contact gempex, the GMP expert. Also in GDP questions always up-to-date!