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Tag: three batch rule ICH

Trends in Multi-Batch Testing for Long-Term Stability Programs

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Trends in Multi-Batch Testing for Long-Term Stability Programs Trends in Multi-Batch Testing Strategies for Long-Term Pharmaceutical Stability Programs Multi-batch testing is a cornerstone of long-term stability programs in the pharmaceutical industry. Regulatory bodies require data from multiple production batches to ensure that the product consistently meets quality specifications throughout its shelf life. As global requirements…

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  • Maintain Backup Stability Chambers to Prevent Data Loss in Case of Failure

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