Module 3 2019

The P.2 Section

• P.2.1 Components of the Drug Product

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P.2.1.1 Drug Substance

P.2.1.2 Excipients

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P.2.2. Drug Product

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P.2.2.1 Formulation Development

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P.2.2.2 Overages

• P.2.2.3 Physicochemical and Biological Properties • Dissolution method development

• P.2.3 Manufacturing Process Development

P.2.4 Container Closure System

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P.2.5 Microbiological Activity

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P.2.6 Compatibility

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The Organisation for Professionals in Regulatory Affairs