CRED Getting the CMC Dossier Right 2024

28/08/2024

Variations

Revised Commission Variation Guidelines (May 2013): EUR-Lex - 52013XC0802(04) - EN - EUR-Lex (europa.eu)

A- Administrative Changes

• E.g. change in the name of the active substance 1AIN

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Variations (cont …)

B. Quality Changes

I. Active Substance

Manufacture

•

Control of active substance

•

Container Closure system

•

Stability

•

• Design Space and post approval change management protocol

Examples of Changes:

• Type 1A (B.I.a.2a) Change in the manufacturing Process of the API

• Type 1B (B.I.d.1.b.3) Change in the storage conditions of an API

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