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Quality by Design: Next Steps to Realize Opportunities? - page 30 / 37

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QbD Questions (Contd.)

How is/should QbD be achieved?

In a structured manner guided by scientific information/knowledge gathered during pre-formulation, development, scale-up, and in production

When is/should QbD achieved?

Ideally for clinical trial material (all major/critical aspects), fine-tune over the life-cycle

How is/should level of QbD be evaluate and measured?

Established relationships (preferably – quantitative /mathematical) between product & process variables and quality attributes  (as in draft PAT Guidance)

How should QbD communicated?

As part of the original submission (e.g., CTD-Q; P2 – Pharmaceutical Development) and/or

Post-approval (supplement or comparability protocol)

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