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Pharma Stability: Insights, Guidelines, and Expertise

Tag: regulatory stability failures

Evaluating Failed Batches in Accelerated Stability Studies

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Evaluating Failed Batches in Accelerated Stability Studies Evaluation Criteria and Regulatory Response for Failed Accelerated Stability Batches Accelerated stability studies are instrumental in predicting product shelf life, but not all batches pass these rigorous tests. When a batch fails under accelerated conditions, it triggers a chain of scientific, quality, and regulatory assessments. This comprehensive guide…

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  • Match Stability Study Container-Closure Systems to Final Market Packaging

    Understanding the Tip: Why container-closure systems matter: Stability testing simulates how a drug product will behave over its shelf life.
    If the container-closure system used… Read more

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