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Pharma Stability: Insights, Guidelines, and Expertise

Tag: ICH Q5C compliance

Real-Time Stability Monitoring and Data Trending in Biologics

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Real-Time Stability Monitoring and Data Trending in Biologics Implementing Real-Time Stability Monitoring and Data Trending for Biopharmaceuticals Stability testing generates critical data used to determine shelf life, ensure product quality, and support regulatory filings. However, the traditional approach of static testing lacks responsiveness to ongoing trends. Real-time monitoring and data trending introduce a proactive layer…

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Stability Testing for Biopharmaceuticals, Stability Testing Types

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  • Establish SOPs for Sample Withdrawal, Recording, and Testing in Stability Studies

    Understanding the Tip: Why SOPs are critical in stability operations: Standard Operating Procedures (SOPs) are the backbone of controlled, reproducible, and compliant pharmaceutical operations.
    In… Read more

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