by Dr. Yashashwini Reddy | May 6, 2025
Qualified Persons (QPs) play a critical role in the pharmaceutical industry by overseeing the safety, efficacy, and compliance of medicines. They are responsible for ensuring that pharmaceutical products meet stringent regulatory standards and are safe for public use....
by Dr. Yashashwini Reddy | May 5, 2025
The quality of pharmaceutical products is crucial for ensuring their safety, efficacy, and reliability. When pharmaceuticals are substandard, they pose significant health risks, including treatment failures, adverse reactions, and even death. Various factors can...
by Dr. Yashashwini Reddy | Apr 29, 2025
The essential GMP (Good Manufacturing Practice) compliance requirements for pharmaceuticals are designed to ensure the consistent production of high-quality, safe, and effective medicinal products. These requirements are globally recognized and enforced by regulatory...
by Dr. Yashashwini Reddy | Mar 30, 2025
Common Technical Document (CTD) for Regulatory Submission In the pharmaceutical industry, regulatory submissions are a crucial step in bringing new drugs to the market. One of the most widely accepted formats for regulatory submissions is the Common Technical Document...
by Dr. Yashashwini Reddy | Nov 27, 2024
Interview Questions and Answers for Drug Substance (3.2.S) in CTD – Regulatory Affairs (Freshers) 1. What is the role of 3.2.S in the CTD (Common Technical Document)? Answer: The 3.2.S section of the CTD is dedicated to the “Drug Substance,” which...
