Module 3 Presentations

07/05/2024

3.2.P.2.1.1 Drug Substance (name, dosage form) • Compatibility of the drug substance with excipients • 3.2.P.2.1 Components of the Drug Product

Key physicochemical characteristics (e.g., water content, solubility, particle size distribution, polymorphic or solid state form) of the drug substance that can influence the performance of the drug • For products with more than one drug substance, the compatibility of drug substances with each other 3.2.P.2.1.2 Excipients (name, dosage form) • Choice of excipients listed in 3.2.P.1, their concentration, their characteristics that can influence the drug product performance (e.g. stability, bioavailability) or manufacturability • Should include all substances used in the manufacturer, even if they do not appear in the finished product (e.g. processing aids)

The Organisation for Professionals in Regulatory Affairs

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• P.2.1.1 Relevant information on the drug substance for the dosage form • Particle size, solubility, moisture content, polymorphism, crystallinity, purity….. 3.2.P.2.1 Components of the Drug Product

Potential Impact of Drug Substance characteristics on Drug Product Attributes

The Organisation for Professionals in Regulatory Affairs

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