Module 3 2019

Quality by Design (QbD)

• Define the Target Product Profile

• Determine Critical Quality Attributes

• Link input material attributes and process parameters to CQAs

Perform Risk Assessment

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• Work programmes to mitigate the risk(s)

• Design Space(s) for formula/process

• Design and implement Control Strategy

Manage product life cycle

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Continuous Improvement

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The Organisation for Professionals in Regulatory Affairs