by Dr. Yashashwini Reddy | Aug 29, 2025
1. Purpose To describe the procedure for performing microbiological integrity testing of sealed vials to ensure container closure integrity and sterility assurance. 2. Scope This SOP applies to all finished sterile product vials manufactured in the facility that...
by Dr. Yashashwini Reddy | Aug 28, 2025
1.0 Purpose To describe the standard procedure for the safe and effective operation of the Fogster-ULV (Ultra-Low Volume) Fogger Machine for disinfection of classified and controlled areas in the facility. 2.0 Scope This SOP applies to all trained personnel...
by Dr. Yashashwini Reddy | Aug 18, 2025
🌟 What Does Quality Really Mean for Pharmaceuticals? In the pharmaceutical industry, quality is far more than just meeting specifications — it is about safeguarding patient health, ensuring regulatory compliance, and maintaining trust. 🔹 Patient Safety First – Every...
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
Importance of Validation in Pharmaceuticals Validation in pharmaceuticals is a critical quality assurance tool that ensures products are consistently manufactured to meet predetermined specifications and regulatory requirements. Its importance can be summarized as...
