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 | Apr 28, 2024
In the Pharmaceutical industry, stainless steel is used as per 21 CFR Part 211 Subpart – D Equipment, sec. 211.5, this guideline says that in pharmaceutical manufacturing, equipment product contact parts should be non-reactive, to achieve this stainless steel is...
