CRED Getting the CMC Dossier Right 2024

05/09/2024

Validation Requirements • Process Validation EMA/CHMP/CVMP/QWP/BWP/70278/2012 • The documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes.

• It is not a one-off event but should be part of product lifecycle

• Continuous process verification may also be possible

• Financial considerations as it is unlikely that the validation batches described in initial application dossier can be commercialised

• Concurrent validation for specific examples

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Validation for Different Dosage Forms

Non-sterile (e.g. tablets, capsules)

Sterile

Biological (not ATMP)

Validation Can use pilot scale (>100, 000 units) batches. Process

Full scale validation and media fills needed for e.g. aseptic process

Full scale validation and media fills needed in dossier

Validation Scheme for commercial scale in 3.2.R

Facilities GMP (not in dossier)

GMP (not in dossier)

3.2.A.1 Facilities and Equipment in dossier Manufacture of Biological active substances and medicinal products for Human use - Annex 2

EU Guide Eudralex Vol 4

Qualification and Validation - Annex 15

Manufacture of Sterile Medicinal Products - Annex 1

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