by Dr. Yashashwini Reddy | Aug 18, 2025
📘 Preparation of Batch Packaging Record (BPR) A Batch Packaging Record (BPR) is a controlled document that provides a detailed account of the packaging process for a specific batch of a pharmaceutical product. It ensures traceability, compliance with GMP, and...
by Dr. Yashashwini Reddy | Aug 12, 2025
How to Submit a DMF (Drug Master File) A Drug Master File (DMF) is a confidential document submitted to the U.S. FDA that contains detailed information about the manufacturing, processing, packaging, and storage of drug substances, intermediates, or components.It is...
by Dr. Yashashwini Reddy | May 2, 2025
Structure of a URS Document for Pharmaceutical Equipment A well-structured URS should include the following key sections: 1. Title Page Document title (e.g., “User Requirement Specification for [Equipment Name]”) Document number and version Prepared by /...
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,...
by Dr. Yashashwini Reddy | Oct 18, 2024
Developmental Quality Assurance (DQA) in Pharmaceuticals The Developmental Quality Assurance (DQA) department plays a crucial role in ensuring the quality and compliance of pharmaceutical products during their development phase. This department works alongside...
