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 29, 2025
Analysis of Out of Specification (OOS) Occurrences in Pharmaceutical Products In the pharmaceutical industry, the term Out of Specification (OOS) refers to situations where the results of tests or measurements fall outside the predefined limits or specifications set...
by Dr. Yashashwini Reddy | Apr 19, 2025
1. What is OOS in the pharmaceutical industry? OOS stands for “Out of Specification.” It refers to test results that fall outside the predefined acceptance criteria set by regulatory authorities or internal specifications. Interviewers want to ensure you...