CRED Getting the CMC Dossier Right 2024

28/08/2024

Backhand: Key guidelines for CMC information in 3.2.P

P.1: Description and Composition

ICH M4Q (R1), EMA NtA Vol. 2B

of the Drug Product

P.2: Pharmaceutical Development

ICH Q8 (R2), EMA NtA Vol. 2B

P.3: Manufacture

EMA guideline „Manufacture of finished Dosage Form“, ICH Q12

P.4: Control of Excipients

EMA „ Excipients in the Dossier of a Medicinal Product “; Phamacopeias Regulation 231/2012 (food additives)

P.5: Control of Drug product

ICH Q2/ 3/ 4/ 6; Pharmacopoeias (monographs for dosage forms and analytics)

P.6: Reference Standards or Materials --

P.7: Container Closure System

EMA „ Plastic Immediate Packaging materials “, Pharmacopoeias

P.8: Stability

ICH Q1 series, EMA scientific guidelines on stability

3.2.R/ 3.2.A

ICH M4Q (R1); EMA NtA Vol. 2B, national HA requirements

The Organisation for Professionals in Regulatory Affairs

Getting the CMC dossier right – module 3.2.P

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