Good Distribution Practices are comprehensively regulated in the EU. The resulting requirements for transporters and warehouse operators are set out in detail and are not necessarily easy to implement. These are real challenges, the implementation of which in practice always means a lack of clarity and a definite need for interpretation. In order to implement a GMP/GDP QM system that is inspection-ready and therefore reliable, yet still makes economic sense, it is absolutely necessary to have outside expertise at one point or another.
The live online seminar "GDP for active ingredients (APIs)“ offers first-hand knowlege. Dr. Martin Melzer, Principal Consultant at gempex and former GMP inspector and GMP/GDP consultant with many years of experience, will speak on the topics of "GDP-compliant transport" and "GDP-compliant storage" of active ingredients for human and veterinary medicinal products.
Based on the regulations and guidelines presented in advance, which cover the entire framework, he illuminates the implementation in daily operations. The important temperature monitoring of the vehicles used for transport is shown, as is the qualified selection of an external transport service provider, which must be evaluated according to clear criteria (rationales). Traceability, i.e. the complete traceability of defined quality criteria, such as a specified and uninterrupted storage and transport temperature, is discussed and illustrated with examples. Finally, the topic of data integrity and the merchandise management systems used will be discussed.
A registration option for the event is provided on the website of the organizer Concept Heidelberg.
The gempex expert team will be happy to answer questions on GDP or GDP for active ingredients via contact@gempex.com .