• Publication Date: 10/01/2008
  • Author(s):
    Vennari, John A.
  • Organization(s):
    West Analytical Services
  • Article Type: Technical Articles
  • Subjects: Nasal Delivery, Quality by Design (QbD), Testing, Validation, and Regulatory Compliance
Determining hand actuation parameters to comply with FDA recommendations for determining design space for testing of spray pumps and inhalation devices.

Quality by Design (QbD), the latest methodology for improving the safety and efficacy of drug products, presents pharmaceutical companies with an opportunity to revaluate the costs and, more importantly, the safety measures associated with achieving high quality overall. Given the increasingly complex and expensive drug products reaching the market, QbD arguably represents an essential strategy; however, the industry has not yet widely adopted this process, in part due to a lack of understanding about how to apply QbD principles. Selecting the optimal device for a particular drug formulation presents a number of challenges, and the development process for manually activated inhalation products provides a useful illustration of how companies can successfully utilize QbD principles.

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