Module 3 Presentations

07/05/2024

The 3.2.P.2 Section on Pharmaceutical Development

P.2.1 Components of the Drug Product ● P.2.1.1 Drug Substance summary (solubility, stability, polymorphs, PSD) ● P.2.1.2 Excipients (compatibility studies, functionality) P.2.2. Drug Product ● P.2.2.1 Formulation Development (e.g. suspension to capsules to tablets….) ● P.2.2.2 Overages ● P.2.2.3 Physicochemical and Biological Properties P.2.3 Manufacturing Process Development P.2.4 Container Closure System P.2.5 Microbiological Activity P.2.6 Compatibility

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Dossier requirements for Pharmaceutical Development section (3.2.P.2)

The Pharmaceutical Development section should describe the knowledge that establishes that the type of dosage form selected and the formulation proposed are suitable for the intended use . This section should include sufficient information in each part to provide an understanding of the development of the drug product and its manufacturing process . At a minimum, those aspects of drug substances, excipients, container closure systems, and manufacturing processes that are critical to product quality should be determined and control strategies justified. Critical formulation attributes and process parameters are generally identified through an assessment of the extent to which their variation can have impact on the quality of the drug product.

Source: ICH guideline Q8 (R2) on pharmaceutical development

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