Non-Compendial Product Quality Screening Draws US FDA’s Criticism

Third-party screening of US-marketed drug products is worse than pointless if done with subpar test methods, agency tells PDA/FDA meeting. Meanwhile, release-testing with such methods has been triggering warning letters.

Dissolution testing apparatus
fda: dissolution should be tested the usp way or something like it • Source: Shutterstock

US Food and Drug Administration officials recently criticized independent third parties and drug product manufacturers for not using US Pharmacopeia compendial or comparable methods when testing drug product quality.

Speaking at the 18-20 September Parenteral Drug Association/FDA conference, they outlined why they believe organizations should not rely on such third-party quality testing, while recapping warning

Key Takeaways
  • The FDA sees no need to independently test marketed drug products for quality.

  • Any such testing should use compendial or comparable methods

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Generics

More from Pink Sheet