Module 3 2019

Pharmaceutical Development and Manufacture of Drug Product

• Information and data ( A COHERENT STORY ) on the development studies conducted to establish

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The dosage form

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The formulation

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The manufacturing process

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The container closure system

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Microbiological attributes

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Usage instructions…..

• Identify and describe the formulation and critical parameters that may influence batch reproducibility, product performance and drug product quality

• An overview of the product control strategy and provides justification for any of the registered content in P3

The Organisation for Professionals in Regulatory Affairs