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Pharma Stability: Insights, Guidelines, and Expertise

Tag: FDA stability deviation guidelines

Handling Deviations and CAPA in Pharmaceutical Stability Reports

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Handling Deviations and CAPA in Pharmaceutical Stability Reports Handling Deviations and CAPA in Pharmaceutical Stability Reports Introduction Stability Studies play a pivotal role in determining the shelf life and storage conditions of pharmaceutical products. However, despite strict protocols and controls, deviations may occur—ranging from Out-of-Trend (OOT) results and chamber excursions to data integrity issues. Effectively…

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Handling Deviations and CAPA in Stability Reports, Protocols and Reports

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  • Store Stability Samples from Validated Commercial Batches for Accurate Shelf-Life Data

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