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: 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 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 18, 2025
📌 Rotameter A Rotameter is a simple, reliable device used to measure the flow rate of liquids and gases in pharmaceutical, chemical, and other industries. It belongs to the variable area flowmeter family. 🔬 Principle of Rotameter Works on the variable area principle:...
by Dr. Yashashwini Reddy | Sep 18, 2025
1. Objective Demonstrate that the proposed purified water generation and distribution system is designed, specified and documented such that, when built and operated as designed, it will consistently produce Purified Water that meets USP requirements and is suitable...
