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Current Expectations Guidance Data Integrity
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Current Expectations Guidance Data Integrity
Website URL:
https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM518522.pdf
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Why write a guidance? FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. 21 Warning Letters have involved data integrity
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