Design Space Development and Verification
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*Christine M.V. Moore, FDA/CDER/ONDQA 


Design space is defined in ICH Q8(R2) as “the multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality.” Movement within an approved design space can be performed under a firm’s quality system without notification to regulatory agencies. A challenge for the developer, manufacturer and regulatory reviewer is how to establish and verify a design space such that it will continue to provide assurance of quality. This presentation will discuss some strategies for design space development and for maintenance of the design space over the product lifecycle.