by Dr. Yashashwini Reddy | Sep 6, 2025
Current Good Manufacturing Practices (cGMP) in Pharmaceutical Industries Current Good Manufacturing Practices (cGMP) are the regulatory standards enforced by agencies like the USFDA, WHO, and EMA to ensure that pharmaceutical products are consistently produced and...
by Dr. Yashashwini Reddy | Jun 30, 2025
📘 Regulations: Good Clinical Practice (GCP) and Clinical Trials Good Clinical Practice (GCP) is an international ethical and scientific standard for designing, conducting, monitoring, recording, auditing, analyzing, and reporting clinical trials that involve human...
by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module VIII – Post-Authorization Safety Studies (PASS) 📘 Purpose GVP Module VIII provides guidance on the design, conduct, and reporting of Post-Authorization Safety Studies (PASS) conducted by Marketing Authorization Holders (MAHs) after a product has been...
by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module VII – Periodic Safety Update Report (PSUR) 📘 Purpose GVP Module VII provides guidance on the preparation, submission, and assessment of Periodic Safety Update Reports (PSURs) by Marketing Authorization Holders (MAHs).It ensures the continuous benefit-risk...
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....
