CRED Getting the CMC Dossier Right 2024

28/08/2024

CMC info in the Common Technical Document

3.2.P Drug Product (DP)

Functional area

3.2.P.1 Description and Composition Characterisation

3.2.P.2 Pharmaceutical Development Characterisation

3.2.P.3 Manufacture

Manufacture

3.2.P.4 Control of Excipients

Control

Module 3

3.2.P.5 Control of Drug Product

Control

3.2.P.6 Reference standards

Control

3.2.P.7 Container Closure System

Manufacture

3.2.P.8 Stability

Characterisation

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

The Organisation for Professionals in Regulatory Affairs

CRED: Getting the CMC dossier right – module 3.2.P

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3.2.P.1 Description and Composition of the Drug Product

Your medicine “at a glance ” (tabular presentation):

➢ Components (quantity per unit basis) , their function and quality standard (Pharmacopeia(s) or in-house)

➢ Container (if applicable, also accessories such as dosing devices)

➢ Include :

➢ - What’s in composite components (capsule shells, inks, coating mixtures),

- Processing aids not in final drug product (e.g. for granulation/ coating) or - Provided solvents/ eluents

➢ Declare weigh-in adjustments to real assay/ potency ➢ Ranges are acceptable, e.g. for ingredients for pH adjustment (“q. s.”) Guidance: ICH M4Q (R1), EMA NtA Vol. 2B

The Organisation for Professionals in Regulatory Affairs

Getting the CMC dossier right – module 3.2.P

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