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Tag: shelf life failure drug recall

How Stability Testing Failures Triggered Global Drug Recalls

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How Stability Testing Failures Triggered Global Drug Recalls Stability Testing Failures Behind Global Drug Recalls: Case Studies and Lessons Learned Introduction Pharmaceutical recalls are often the result of product quality failures identified either during post-marketing surveillance or through internal investigations. A significant percentage of global drug recalls are directly tied to deficiencies in stability testing—ranging…

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Case Studies in Stability Testing, How Stability Testing Influenced Global Drug Recalls

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  • Align Stability Testing with Label Claims to Ensure Scientific and Regulatory Consistency

    Understanding the Tip: Why label-linked stability testing is essential: Pharmaceutical labels convey critical information that governs product handling, administration, and storage.
    Claims such as “Protect… Read more

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