EMA draft QP declaration template Contribution from Cornelis written on 2/7/2012 at 09:38
The (draft) EMA template for the Qualified Person's declaration describes in PART D the "verification of the active substance supply chain traceability". One has to declare that the supply chain has been established and is documented, there exists a documented risk assessment and the documents are available for inspection. We already receive questions on this declaration and I was wondering if any of you already has experience with this template, and on what basis you declare the points mentioned in PART D. What information is minimum to be able to verify the supply chain traceability, what documents do you have available, what information do you have in your "documented risk assessment"? Any insight would be very welcome. Answers to this contribution:
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