by Dr. Yashashwini Reddy | May 2, 2025
Common Sources of Contamination in Pharmaceutical Manufacturing Contamination in pharmaceutical production can lead to serious consequences, including compromised product quality, patient safety risks, regulatory violations, and financial losses. Contamination can be...
by Dr. Yashashwini Reddy | Apr 25, 2025
Standard Operating Procedure (SOP) Here’s a clear and structured Standard Operating Procedure (SOP) for Garment Change and Entry/Exit through the First and Primary Change Room, typically used in controlled environments like...
by Dr. Yashashwini Reddy | Apr 23, 2025
Standard Operating Procedure (SOP) Here is a Standard Operating Procedure (SOP) for the Cleaning of the Quality Control (QC) Department Throughout Working. This SOP ensures that the QC area remains clean and contamination-free during...
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,...
