CRED Getting the CMC Dossier Right 2024

28/08/2024

3.2.P.4 Control of Excipients

Control

Specification, Analytical Procedures & Validation, Justification of Spec. ➢ Compendial: reference to pharmacopoeia is sufficient (add CoA) ➢ Composite exicipients: qualitative/ quantitative description (flavours!)

Excipients of Human or Animal Origin ➢ Adventitious agent information/ TSE declarations (balance with 3.2.A.2)

Novel Excipients

➢ Key characteristics of excipients used first time in a drug product (CTD 3.2.A.3 or 3.2.S can be used for complex excipients, e.g. liposomes)

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

The Organisation for Professionals in Regulatory Affairs

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3.2.P.5 Control of Drug Product [1]

Control

Specification ➢ Tabular presentation of quality attributes, limits and analytical procedure references ➢ Consider different scopes (e. g. batch release/ shelf-life/ in-use)

Analytical Procedures ➢ Description with sufficient detail that competent laboratories can repeat tests; refer to compendial methods, if applicable

Validation of Analytical Procedures

➢ Evaluate performance as per ICH Q2; not needed for compendial tests

Guidance: ICH Q2/ 3/ 4/ 6; Pharmacopoeias (including monographs for dosage forms and test methods)

The Organisation for Professionals in Regulatory Affairs

Getting the CMC dossier right – module 3.2.P

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