Managing Risks to Time Critical Product Imports at Clinical Supply Depots
Summary: A 天美影院 customer wanted to run a clinical trial in Israel and was arranging to ship their clinical trial product from a non-天美影院 facility in Europe to a 天美影院-managed and audited depot in Israel. With the protocol based in the US and the investigational medicinal product (IMP) approved in the EU, the customer incorrectly assumed and, without checking further requirements, that Israel had the same QP (qualified person) approval process as the EU. This case study outlines the steps that 天美影院 took to ensure the QP release process could quickly advance in Israel while simultaneously updating the warning labels to meet the QP requirements.