by Dr. Yashashwini Reddy | Sep 23, 2025
Case Study: Supply Chain Disruption – API Shortage Background A U.S.-based pharmaceutical company manufacturing essential cardiovascular and anti-diabetic medicines faced a sudden API (Active Pharmaceutical Ingredient) shortage in 2024. The primary API supplier was...
by Dr. Yashashwini Reddy | Sep 9, 2025
🔑 Tips for Effective Internal Audit System Establish Clear Objectives Define the purpose of the audit (compliance, efficiency, risk identification, or process improvement). Develop a Comprehensive Audit Plan Prepare a risk-based annual audit schedule covering all...
by Dr. Yashashwini Reddy | Aug 18, 2025
Quality System in Pharmaceuticals A Quality System in pharmaceuticals is the framework that ensures drugs are consistently developed, manufactured, tested, and distributed in compliance with Good Manufacturing Practices (GMP), regulatory requirements, and patient...
by Dr. Yashashwini Reddy | Aug 18, 2025
Contamination Control Strategies for Manufacturing Area In pharmaceutical manufacturing, contamination control is critical to ensure product quality, patient safety, and regulatory compliance. Contamination can occur in the form of particulate, microbial, chemical, or...
by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module X – Additional Monitoring 📘 Purpose GVP Module X outlines the principles and procedures related to “Additional Monitoring” of certain medicines to enhance early identification of new safety information. It ensures transparency and helps promote reporting...
