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 29, 2024
Interview Questions and Answers for Corporate Quality Assurance in Pharmaceuticals General QA Role Question: What is the role of Corporate Quality Assurance (CQA) in a pharmaceutical company? Answer: CQA ensures consistent quality and compliance across all...
by Dr. Yashashwini Reddy | Nov 28, 2024
Out of Specifications (OOS) in Pharmaceuticals Out of Specification (OOS) results occur when the test results of a pharmaceutical product fall outside the predefined acceptance criteria specified in regulatory guidelines or quality standards. These deviations are...
by Dr. Yashashwini Reddy | Nov 28, 2024
Drug Approval Process in India: Simplified Steps Getting a new drug approved in India involves multiple steps to ensure safety, effectiveness, and quality. Here’s a simplified overview: 1. Pre-Clinical Testing Laboratory Testing: Conducted on cells and animals to...
by Dr. Yashashwini Reddy | Nov 25, 2024
Methods of Depyrogenation in the Pharmaceutical Industry Introduction Depyrogenation refers to the removal of pyrogens, primarily bacterial endotoxins, from pharmaceutical products and equipment. Pyrogens can cause severe immune reactions, making their elimination...
