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Gaps in statistical approaches to control of delivered dose uniformity throughout product lifecycle

  • Publication Date: 02/01/2014
  • Author(s):
    Christopher, David Friedman, Emil Golden, Michael Larner, Greg Lyapustina, Svetlana Starbuck, David Strickland, Helen
  • Organization(s):
    International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS)
  • Article Type: Technical Articles
  • Subjects: Device Design, Devices and Components, Industry Issues and Trends, Product Development/Formulation, Testing, Validation, and Regulatory Compliance
Quality management should be adjusted throughout product lifecycle to minimize the probability of false rejection and false acceptance errors.

A lasting solution would be the adoption of sample-independent quality standards and statistical process controls, for example, by incorporating in the pharmaceutical industry some of the statistical methods standardized by ASTM, ISO and other standard-setting organizations, appropriately adjusted throughout a product’s lifecycle (from early to late development to commercial production).

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