by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module VI – Addendum I: Duplicate Management of Suspected Adverse Reaction Reports 🔹 Purpose This Addendum to GVP Module VI provides guidance on how Marketing Authorisation Holders (MAHs) and National Competent Authorities (NCAs) should manage duplicate...
by Dr. Yashashwini Reddy | Jun 23, 2025
🔹 Introduction Drug development is a complex, multi-phase process aimed at discovering, designing, testing, and bringing new therapeutic products to market. Ensuring the safety and efficacy of these medicines is not a one-time task—it continues long after approval....
by Dr. Yashashwini Reddy | Jun 9, 2025
🔹 What is Contamination in Pharma Manufacturing? Contamination refers to the unintended presence of chemical, microbial, particulate, or cross-substance materials in a product or manufacturing environment. It can affect product safety, efficacy, and regulatory...
by Dr. Yashashwini Reddy | Apr 28, 2025
Introduction Quality is a cornerstone of the pharmaceutical industry because it directly affects patient safety, therapeutic effectiveness, and public trust. When we talk about “quality standards,” we refer to the strict guidelines, procedures, and...
by Dr. Yashashwini Reddy | Dec 1, 2024
Classification of GMP Deficiencies: A Comprehensive Guide for Pharmaceutical Compliance Good Manufacturing Practice (GMP) is a cornerstone of pharmaceutical manufacturing, ensuring that products are produced and controlled according to rigorous quality standards....
