Module 3 2019

P.2.2.3 Physicochemical and Biological Properties

• This section describes, the control, improvements of the manufacturing process described in 3.2.P.3.3

• Choice of manufacturing process

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Process optimization

• Differences (if any) between clinical and commercial manufacture • Pivotal/stability batches • Relationships between Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs)

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Control Strategy •

Design Space/Control Space

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Proven Acceptable Range (PAR)

Normal Operating Range (NOR )

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The Organisation for Professionals in Regulatory Affairs