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 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
🔹 For Patients Access to New Treatments Early Patients may gain access to investigational drugs, biologics, or devices before they’re widely available. This can be especially important when current treatments are limited or ineffective. Closer Medical Monitoring...
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...
by Dr. Yashashwini Reddy | Sep 20, 2025
1. Purpose To establish guidelines for maintaining personal hygiene of all personnel to ensure product safety, prevent contamination, and maintain a clean working environment. 2. Scope This SOP applies to all employees, contract workers, visitors, and service...
