Specialists in Sterile Products and Processes

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Quality by Design and Design of Experiment

In today’s regulatory landscape for the lyophilized pharmaceuticals, complete formulation characterization and robust lyophilization process that is scale and site independent is essential part of the development process. Moreover, QbD principles for freeze-drying process design and development are absolutely essential and several tools must be used to monitor and control the freeze-drying process in real time so that the quality can be built within the process rather than monitoring offline at the end of the process.

The application of quality by design (QbD) in pharmaceutical product development is now mandated by the US-FDA, ICH and other worldwide regulatory authorities. Inclusion of QbD related considerations are now part of the new question-based review of the chemistry, manufacturing, and controls (CMC) section of regulatory submissions and when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are the necessary elements during the development phase and KAMAT knows how to successfully navigate…