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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.

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.

See how real-time density measurements   can streamline process control and satisfy regulatory scrutiny in our roller-compaction video!

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

Gas pycnometry in less than three minutes – have a closer look yourself

Envelope density analysis to optimize your manufacturing process– seeing is believing

Claim our special price today and benefit to better control compactor ribbon formation and thus tablet production.