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Pharma Stability: Insights, Guidelines, and Expertise

Tag: annual stability testing

Stability Commitment Studies for Marketed Products

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Stability Commitment Studies for Marketed Products How to Conduct Stability Commitment Studies for Marketed Pharmaceutical Products Once a pharmaceutical product is approved and enters the market, regulatory responsibilities do not end. A key ongoing obligation is to conduct stability commitment studies for marketed products. These studies confirm that commercial-scale batches remain within specification throughout their…

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  • Calibrate and Validate RH Sensors and Data Loggers to Maintain Stability Compliance

    Understanding the Tip: Why RH sensors and data loggers require control: Relative humidity (RH) sensors and data loggers are essential for ensuring that stability chambers… Read more

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