by Dr. Yashashwini Reddy | May 19, 2025
A Systematic Investigation of Out-of-Specification (OOS) Results in Analytical Testing is a structured approach to identify, evaluate, and resolve instances where test results fall outside predefined specifications. This process is vital in pharmaceutical quality...
by Dr. Yashashwini Reddy | Apr 28, 2025
“Factors Contributing to Out-of-Specification Outcomes” refers to the various reasons or elements that can cause a product, process, or system to fall outside the defined limits or specifications. These factors are critical in industries such as...
by Dr. Yashashwini Reddy | Apr 28, 2025
Investigation of OOS (Out of Specification) Results in Analytical Testing In the context of pharmaceutical and biotechnology industries, Out of Specification (OOS) results refer to test results that fall outside the predefined acceptance criteria for a given product...
by Dr. Yashashwini Reddy | Oct 18, 2024
Understanding the Difference Between Out of Trend (OOT) and Out of Specification (OOS) in Pharmaceuticals In the pharmaceutical industry, maintaining product quality and regulatory compliance is critical. Two key terms often encountered in quality control are Out of...
