1. Generics Bulletin

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

 
• By Bowman Cox

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.

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