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 ensure compliance.
Out of Trend (OOT) Results in Pharma Industry
Learn how to detect, manage, and investigate Out-of-Trend (OOT) results in pharma to maintain product quality, ensure GMP compliance, and prevent OOS issues.
Out of Specification Results: Dealing with OOS Investigations in Pharma
Learn about all the phases of addressing Out of Specification (OOS) results in the pharmaceutical industry
5 Key Differences Between OOS, OOT and OOE Results
Look into the five key differences between OOS, OOT, and OOE results, the regulatory requirements and their importance in the GMP.