by Dr. Yashashwini Reddy | Sep 26, 2025
📌 Case Study: Ranbaxy Laboratories – Data Falsification & GMP Violations Background:Ranbaxy Laboratories, once India’s largest generic drug manufacturer, faced one of the biggest regulatory scandals in the pharmaceutical industry. In 2013, the company admitted to...
by Dr. Yashashwini Reddy | Sep 23, 2025
📌 Case Study: COVID-19 Vaccine Development – Pfizer/BioNTech 🧩 Background In early 2020, the COVID-19 pandemic created an urgent global demand for a safe and effective vaccine. Pfizer (U.S.) partnered with BioNTech (Germany) to develop an mRNA-based vaccine (BNT162b2,...
by Dr. Yashashwini Reddy | Sep 23, 2025
📝 Case Study: OOS Investigation – Tablet Dissolution 📍 Background A marketed immediate-release tablet showed dissolution failure during routine quality control testing. Specification: NLT (Not Less Than) 80% drug release in 30 minutes. Observed result: 60–65% release...
by Dr. Yashashwini Reddy | Sep 23, 2025
📌 Case Study: Data Integrity Failures – FDA Warning Letters 1. Background In recent years, several pharmaceutical companies (especially in India and China) have faced FDA Warning Letters and import alerts because of data integrity violations. These cases highlight the...
by Dr. Yashashwini Reddy | Sep 22, 2025
WHO Guidance on Cross-Contamination Definition:Cross-contamination is the unintended presence of one product (or its residues, microbes, cleaning agents, etc.) in another product. Prevention Measures (as per WHO TRS, GMP guidelines): Dedicated facilities or equipment...
