by Dr. Yashashwini Reddy | Apr 25, 2025
Standard Operating Procedure (SOP) Here’s a detailed Standard Operating Procedure (SOP) for the Bubble Point Test, which is commonly used to verify the integrity of membrane filters—especially in sterile pharmaceutical or biotech processes....
by Dr. Yashashwini Reddy | Apr 22, 2025
Standard Operating Procedure (SOP) 1. Purpose To define the procedure for sampling of primary, secondary, and tertiary packing materials to ensure that the materials received conform to the required quality standards before use in production. 2....
by Dr. Yashashwini Reddy | Apr 19, 2025
1. What are GLP, GDP, and GMP, and how do they differ? This foundational question tests your understanding of the definitions: GLP: Ensures integrity and quality of non-clinical lab studies. GDP: Ensures data integrity and accuracy in documentation. GMP: Ensures...
by Dr. Yashashwini Reddy | 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,...
