Tag: Good Documentation Practices

Never Delete Original Data — Follow ALCOA+ Principles in Stability Studies

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Understanding the Tip: Why original data must be preserved in stability studies: In the context of GMP-compliant stability testing, original data serves as the foundational evidence of product quality, regulatory compliance, and scientific integrity. Deleting, overwriting, or modifying raw data compromises traceability and may be construed as data falsification. Whether the data is paper-based or…

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Stability Study Tips

Apply Good Documentation Practices (GDP) to Stability Data

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Understanding the Tip: Why GDP is critical for stability studies: Stability data plays a vital role in determining the shelf life, storage conditions, and quality of pharmaceutical products. Every detail—test result, observation, or correction—must reflect the actual process without ambiguity or error. Applying Good Documentation Practices (GDP) ensures that the data captured is trustworthy, attributable,…

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Stability Study Tips