Tag: OOS

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fda-warning-letter-analysis

FDA Warning Letter Analysis: Chem-Tech, Ltd. – Deficiencies in OOS Investigation, Cleaning Validation and More

FDA issues a warning letter to Chem-Tech, Ltd. for improper OOS investigations, unvalidated cleaning procedures, and poor quality oversight. Key...
fda-warning-letter-analysis

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...
Evaluation of Out of Trend Results in Pharmaceutical Industry

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...
Out of Specification Results Dealing with OOS Investigations in Pharma

Out of Specification Results: OOS Investigations in Pharma

Learn about all the phases of addressing Out of Specification (OOS) results in the pharmaceutical industry...
Differences Between OOS, OOT and OOE Results

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...

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