Module 5 Presentations

05/07/2024

GMP for APIs (DS)

• All IMPs to be manufactured in accordance with the principles of GMP • For NCE – not normally necessary to demonstrate EU-GMP compliance • For biologicals – necessary to demonstrate EU-GMP compliance due to complexity (GMP Annex 2) – GMP verification needed – Must be demonstrated in CTA

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GMP Compliance

Evidence of GMP compliance for manufacturer Req.Docs Scenario

MA (IMP)

GMP Cert.

QP Declaration

NCE, EU manuf. sites only NCE, inc. non-EU manuf. Sites Biological, EU manuf. Sites only Biological, inc. non EU manuf. Sites

All DP

N/A

All sites involved in DP packaging, labelling, importation, batch certification (manufacturing steps)

All DP sites (where available) All DP and DS manufacturing sites All DP andDS sites (where available)

For all non-EU DP manufacturing sites

N/A

For all non-EU DP and DS sites

Reconstitution

Not required

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