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Tag: OOS

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FDA Highlights Systemic Issues at Mylan Laboratories in Recent Warning

FDA warns Mylan Laboratories for critical cGMP violations in quality control, data integrity, and governance, urging urgent corrective actions to...

Learn how to detect, manage, and investigate Out-of-Trend (OOT) results in pharma to maintain product quality, ensure GMP compliance, and...

Learn about all the phases of addressing Out of Specification (OOS) results in the pharmaceutical industry...

Look into the five key differences between OOS, OOT, and OOE results, the regulatory requirements and their importance in the...