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QbD, Process Des. and Control, Reg. Approvals


Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control. Achieving QbD requires an in-depth understanding of physicochemical properties of all solid form feeds, intermediates and products.

Early identification of Critical Quality Attributes (CQA’s) of excipients and Active Pharmaceutical Ingredients (API’s) and their contribution to a formulation is a key component of QbD.

Micromeritics instruments and contract analytical services offer solutions for:

  • The early identification of CQA’s
  • Knowledge-based process optimization
  • Process monitoring

Which is the foundation for successful QbD.

With the demands of Chemistry and Manufacturing Control (CMC) embedding QbD into the development of a drug production strategy. Thus, demanding proof of a high-level understanding of the physicochemical properties of not just the API, but also the excipients; and how these are altered as they are blended and combined in each of the processing steps.

There is a rapidly increasing demand for wider ranging characterization techniques and fuller characterization of intermediates but less acceptance of unsupported finished dosage form characterization.

Historically particle size has been the dominant physical characteristic used as a process control parameter. This in-process test would then be supported by additional physical characterization on the final product for release. However, this is increasingly seen as bad practice, and additional properties such as surface area, porosity, particle shape, density, and surface morphology are also being used for process control, and not just for final product characterization. Additionally, these are frequently used as predictive tools for process design and optimization. They can also be key tools in process risk management, where they are used to reduce possible manufacturing failures by alleviating scale-up issues and minimize process variation effects on the final product quality.

Learn more about what we have to offer to optimize your drug production processes and ensure quality standards.