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Qualification, Monitoring and Challenges in Working with International Suppliers
Author: Elaine Dymond, Vice President, Quality, Catalent Pharma Solutions
This presentation discusses the challenges faced by the Pharma industry in dealing with suppliers from within the EU vs. USA / Rest of World as well as understanding the diversity of rules and regulations associated with supply. It looks at these challenges from within the EU and in meeting QP (Qualified Person) requirements. Also touched upon within this presentation are the EU GMP guidelines in relation to Supplier Quality, and how these must be applied and considered when working with International Suppliers. In conclusion options are provided on how to overcome and mitigate risks associated with the wide range of different products around the world supplied by the same supplier.
