by Naveen kumar | 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 Naveen kumar | 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 Naveen kumar | 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 Naveen kumar | 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 Naveen kumar | 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...
