by Naveen kumar | Nov 28, 2024
Basic Guidelines for Process Validation in Tablet Manufacturing Process validation is a critical component of pharmaceutical manufacturing that ensures each batch of tablets meets quality, safety, and efficacy standards. The following guidelines outline the...
by Naveen kumar | 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 Naveen kumar | 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...
by Naveen kumar | Nov 26, 2024
Interview Questions and Answers for Regulatory Affairs Freshers 1. What is Regulatory Affairs? Answer: Regulatory Affairs involves ensuring that pharmaceutical products comply with regulations and laws concerning drug development, registration, and marketing. It acts...
by Naveen kumar | Nov 25, 2024
Forced Degradation Studies in Pharmaceuticals Introduction Forced degradation studies are essential in the pharmaceutical industry for evaluating the stability of drug substances and formulations. These studies involve exposing drugs to extreme environmental...
