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Shelf Life and Expiry

Shelf Life and Expiry in Pharmaceuticals: Principles, Testing, and Compliance

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Shelf Life and Expiry in Pharmaceuticals: Principles, Testing, and Compliance Understanding Shelf Life and Expiry in Pharmaceutical Products Introduction Shelf life and expiry dates are fundamental to pharmaceutical product quality and patient safety. These parameters determine how long a drug can be stored and used while maintaining its intended potency, safety, and efficacy. The assignment…

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Shelf Life and Expiry

Regulatory Submissions for Shelf Life Extensions in Pharmaceuticals

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Regulatory Submissions for Shelf Life Extensions in Pharmaceuticals Regulatory Submissions for Shelf Life Extensions in Pharmaceuticals Introduction Extending the shelf life of a pharmaceutical product can lead to improved supply chain efficiency, reduced waste, and enhanced profitability. However, shelf life extensions must be scientifically justified and formally submitted to health authorities. Whether in the United…

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Regulatory Submissions for Shelf Life Extensions, Shelf Life and Expiry

Shelf Life and Expiry

  • Shelf Life and Expiry Dating
  • Regulatory Submissions for Shelf Life Extensions
  • Shelf Life Prediction Models and Statistical Approaches
  • Re-Test Period vs. Shelf Life in Pharmaceutical Stability
  • Factors Affecting Drug Shelf Life (Storage Conditions, Packaging, API Stability)
  • Shelf Life vs. Expiration Date: Key Differences

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  • Start Stability Protocol Design with ICH Q1A(R2) Guidance

    Tip: Always refer to ICH Q1A(R2) before designing a stability protocol to align with global regulatory expectations.
    Understanding the Tip: Why protocol design matters: Stability protocols define how long a pharmaceutical product remains safe and effective… Read more

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