Module 3 Presentations

07/05/2024

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 • Work programmes to mitigate the risk(s)

• Design Space(s) for formula/process • Design and implement Control Strategy

• Manage product life cycle • Continuous Improvement

The Organisation for Professionals in Regulatory Affairs

13

Risk Assessment and Mitigation

• Sources of Information • Experience

• Drug, excipients, processing, packaging etc • Materials, facility, plant, test methodology etc • Scientific principles • Technical/Scientific Literature • Vendor(s) for Materials, Packaging etc • Vendor(s) of Equipment/Plant

The Organisation for Professionals in Regulatory Affairs

14