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Tag: ICH Q1B deviation management

Photostability Protocol Deviations and CAPA Handling

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Photostability Protocol Deviations and CAPA Handling Managing Photostability Protocol Deviations and CAPA in Pharmaceutical Stability Programs Photostability studies are integral to the stability testing framework for pharmaceuticals, as defined by ICH Q1B. However, deviations from approved protocols during photostability studies—whether due to equipment malfunction, incorrect sample handling, or documentation errors—can compromise data integrity and regulatory…

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