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Pharma Stability: Insights, Guidelines, and Expertise

Tag: CAPA stability variation

Handling Discrepancies Between Accelerated and Long-Term Stability Data

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Handling Discrepancies Between Accelerated and Long-Term Stability Data Expert Guide to Handling Discrepancies Between Accelerated and Long-Term Stability Data Stability testing is the cornerstone of pharmaceutical product lifecycle management. Typically, both accelerated (e.g., 40°C/75% RH) and long-term (e.g., 25°C/60% RH or 30°C/75% RH) studies are conducted to assess the degradation behavior of drug substances and…

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  • Prepare Expiry Justification Reports to Support Regulatory Queries and Renewals

    Understanding the Tip: What are expiry justification reports: Expiry justification reports are formal documents that summarize the rationale behind an assigned shelf life.
    They compile… Read more

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