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...
by Dr. Yashashwini Reddy | Mar 30, 2025
Module 3: Quality (CMC) in Regulatory Dossier Submission In pharmaceutical regulatory submissions, Module 3 of the Common Technical Document (CTD) plays a critical role in ensuring drug quality, safety, and efficacy. This module, also known as the Quality Module,...
by Dr. Yashashwini Reddy | Nov 13, 2024
In the world of pharmaceuticals, Active Pharmaceutical Ingredients (APIs) and Intermediates are essential yet distinct parts of the drug manufacturing process. Understanding Active Pharmaceutical Ingredients (APIs) An API is the core component of a drug, directly...
by Dr. Yashashwini Reddy | Nov 1, 2024
Understanding the Difference Between Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) in Pharmaceuticals In pharmaceutical manufacturing, maintaining high product quality is essential, and two important concepts—Critical Quality Attributes...
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...
