January 28, 2026

Question from: Masako Ota masako.ota.vx@kyowakirin.com at 2026-01-28 04:15:16

I am submitting these questions on behalf of Kyoko Koizumi who plans to attend the session on 11 Mar.
1) Is it permissible to ship drug product or finished goods from an Asian manufacturing or packaging site to an EU or UK depot before the corresponding Qualified Person (QP) Declaration has been issued?
2) Are QP Audits only required for manufacturing sites outside of the EU/UK?

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