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.
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.
