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Let’s dig deeper: An interview with the authors of “Point of View: A better way to set specifications and control quality—General concepts and examples”

  • Publication Date: 10/01/2025
  • Author(s):
    Christopher, J. David Larner, Greg Lyapustina, Svetlana Morgan, Beth Strickland, Helen
  • Organization(s):
    AstraZeneca Faegre Drinker Consulting International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) Merck
  • Article Type: Technical Articles
  • Subjects: Industry Issues and Trends, Product Development/Formulation, Testing, Validation, and Regulatory Compliance

In 2024, Inhalation published the article “Point of View: A better way to set specifications and control quality—General concepts and examples” from the Product Quality Demonstration Strategy (PQDS) Working Group of the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS). This article presents an interview with the authors, approximately one year after the initial article was published.

In this interview, the authors provide new content, discuss key questions and recommend resources from the literature and regulations that readers may want to consider. Questions include: Why is it so challenging to make a clear connection between quality control (QC) tests and clinical outcomes? How are statistical batch release testing requirements and compendial testing standards related? And in the absence of IVIVC, descriptive statistic parameters of a designated sample from a batch (e.g., the mean emitted dose and dose variability) morphed into batch release criteria. How did that transformation happen?

October 2025, Volume 19(5), pages 10-13

Read the original 2024 article: Point of View: A better way to set specifications and control quality—General concepts and examples

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