by Dr. Yashashwini Reddy | Nov 27, 2024
Q1. Why is microbiology important in the pharmaceutical industry? A: Microbiology ensures that pharmaceutical products are free from microbial contamination. It plays a crucial role in sterility testing, microbial limit testing, and environmental monitoring to...
by Dr. Yashashwini Reddy | Nov 27, 2024
1. What is Developmental Quality Assurance (DQA)? A: Developmental Quality Assurance ensures that quality is built into a product during its development stages. It involves reviewing documents, processes, and protocols to meet regulatory and quality standards...
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...
by Dr. Yashashwini Reddy | Nov 27, 2024
Interview Questions and Answers on Module 3.2.P (Drug Product) Under Quality – CTD 1. What is the 3.2.P section of the CTD? Answer: The 3.2.P section in Module 3 of the CTD deals with the drug product. It provides detailed information about the finished dosage...
by Dr. Yashashwini Reddy | Nov 26, 2024
Interview Questions on Common Technical Document (CTD) for Regulatory Affairs Freshers 1. What is the Common Technical Document (CTD)? Answer: CTD is a standardized format for submitting regulatory documents for drug approvals. It simplifies the submission process...
