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Pharma Stability: Insights, Guidelines, and Expertise

Tag: EMA stability chamber compliance

Validation of Stability Testing Equipment: GMP Strategy for Pharma

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Validation of Stability Testing Equipment: GMP Strategy for Pharma GMP Validation of Stability Testing Equipment in the Pharmaceutical Industry Introduction Validation of stability testing equipment is a foundational requirement in Good Manufacturing Practice (GMP)-compliant pharmaceutical operations. Instruments such as stability chambers, cold rooms, incubators, refrigerators, and freezers used in Stability Studies must undergo documented validation…

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Equipment and Calibration, Validation of Stability Testing Equipment

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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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