Module 5 Presentations

05/07/2024

GMP Compliance Evidence of GMP compliance for manufacturer Req.Docs Scenario

MA (IMP)

GMP Cert.*

QP Declaration

Licenced drug (EU or ICH region) unmodified, EU manufacturing Licenced drug (EU only), unmodified, non-EU manufacturing Licenced drug (ICH region), non-EU manufacturing

N/A

N/A

N/A

N/A

N/A

N/A

All sites involved in DP manufacturing/imp ort

All EUsites

Yes

Where GMP cannot be confirmed analysis required.

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For a Phase I clinical trial of a new biological IMP manufactured in EU, which GMP documents are needed for the Dossier to be validated?

A C B D

No GMP documents

GMP inspection certificate and manufacturer’s authorisation for each site (DS, DP) GMP inspection certificate for each site (DS, DP) and manufacturer’s authorisation for DP sites GMP inspection certificates for DS sites, manufacturer’s authorisation for DP sites

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