by Dr. Yashashwini Reddy | Apr 29, 2025
Quality issues in the pharmaceutical industry can arise from a variety of sources across the entire lifecycle of drug development, manufacturing, and distribution. Below is a detailed breakdown of the root causes: 1. Manufacturing Process Failures Inadequate Process...
by Dr. Yashashwini Reddy | Apr 16, 2025
1. What is SOR spectroscopy, and how does it differ from traditional optical rotation methods? SOR (Stress-Optic Rotation) spectroscopy measures changes in the optical rotation of polarized light as it passes through a material under mechanical stress. Unlike...
by Dr. Yashashwini Reddy | Apr 8, 2025
Various types of regulatory submissions are essential in the pharmaceutical and medical device industries. These include Investigational New Drug (IND) applications for clinical trials, New Drug Applications (NDAs) for new pharmaceuticals, Biologics License...
by Dr. Yashashwini Reddy | Jun 13, 2024
In this article we are going to learn about BMR – Batch Manufacturing Record 1.A BMR is a written documentation containing information on how a batch will be manufactured. 2. It Contains Step by step instructions on how a batch will be manufactured. 3. BMR is...
by Dr. Yashashwini Reddy | Jun 8, 2024
A Trial Master File is a collection of documents in an organized way, and it ensures clinical trials are conducted as per good clinical practices following regulatory requirements. TMF is very important in ensuring that the trial has been managed successfully by the...
