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Tag: EMA shelf life guidance

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

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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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