by Dr. Yashashwini Reddy | May 3, 2025
What is a Factory Acceptance Test (FAT)? A Factory Acceptance Test (FAT) is a formal process where equipment or systems are tested at the manufacturer’s facility before shipment. The goal is to verify that the equipment meets design specifications, functionality, and...
by Dr. Yashashwini Reddy | May 2, 2025
Structure of a URS Document for Pharmaceutical Equipment A well-structured URS should include the following key sections: 1. Title Page Document title (e.g., “User Requirement Specification for [Equipment Name]”) Document number and version Prepared by /...
by Dr. Yashashwini Reddy | May 2, 2025
Revalidation plays a critical role in maintaining product quality and ensuring regulatory compliance in pharmaceutical manufacturing. It is an essential component of Good Manufacturing Practices (GMP) and a requirement by regulatory authorities like the FDA, EMA, and...
by Dr. Yashashwini Reddy | May 2, 2025
The validation of clean room pass boxes is a critical process in pharmaceutical manufacturing, ensuring that these systems effectively maintain a sterile or controlled environment when transferring materials or products between different areas (e.g., from non-sterile...
by Dr. Yashashwini Reddy | May 2, 2025
A Site Acceptance Test (SAT) is a critical phase in the installation and commissioning of equipment, systems, or machinery at a specific location, particularly in industries like pharmaceuticals, manufacturing, and technology. The SAT ensures that all systems or...
