White Paper: Implementing QbD: Powder Characterization For Design Space Definition

By Tim Freeman, Freeman Technology

For those seeking to adopt a Quality by Design approach to pharmaceutical development and manufacture, effective definition of the ‘design space' is a key activity. This paper considers the role of modern powder testers such as the FT4 from Freeman Technology, within this context.

In order to focus both commercial and regulatory resources, the pharmaceutical industry is moving towards a risk-based approach to product development and manufacture. Quality by Design (QbD), the concept of ‘designing in' product quality rather than relying on post-production testing, is an integral part of this process. The implementation of QbD involves targeting a specific product profile, defined on the basis of clinical efficacy and safety, by identifying the factors that influence product performance, and controlling them effectively.

A critical activity is development of the design space - ‘the multidimensional combination and interaction of input variables (eg material attributes) and process parameters that have been demonstrated to provide assurance of quality.' Definition of the design space is part of the regulatory submission and only movement outside it would normally initiate a regulatory post-approval change. This provides a strong incentive for developing sufficient understanding to ensure optimal specification, from the outset.

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