Case Study 1
Import and Qualified Person Release into Europe
A US client contacted Biotec regarding the import of an IMP into Europe for a clinical trial. The major issue being that the drug product had been manufactured in a facility that had subsequently been decommissioned and therefore the site was no longer available for audit. However, Biotec had already audited the current manufacturing facility. The client was working to tight timelines and needed to submit the IMPD as soon as possible.
Biotec are working closely with both the client, the MHRA and the QA department of the manufacturing facility to conduct a full review of the manufacturing process and documents. Upon satisfying himself that the manufacturing process complies with EU GMP, Biotec’s QP will supply the QP declaration required for the IMPD submission.
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