Module 3
3.2.P.8 — Stability
Related Sections
Up to3.2.P — Drug Product3.2.P.1 — Description and Composition
Description of dosage form and quantitative composition including overages
3.2.P.2 — Pharmaceutical Development
Development of dosage form, formulation, manufacturing process, container closure, and microbiological attributes
3.2.P.2.1 — Components of the Drug Product
Drug substance compatibility with excipients, excipient choice rationale
3.2.P.2.2 — Drug Product
Formulation development, overages justification, physicochemical/biological properties
3.2.P.2.3 — Manufacturing Process Development
Manufacturing process development and optimization studies
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