by Dr. Yashashwini Reddy | Nov 28, 2024
Out of Specifications (OOS) in Pharmaceuticals Out of Specification (OOS) results occur when the test results of a pharmaceutical product fall outside the predefined acceptance criteria specified in regulatory guidelines or quality standards. These deviations are...
by Dr. Yashashwini Reddy | Nov 22, 2024
What is a Validation Protocol? A Complete Guide for the Pharmaceutical Industry In the pharmaceutical industry, achieving and maintaining high standards of quality is non-negotiable. A validation protocol is one of the critical tools that ensure processes, equipment,...
by Dr. Yashashwini Reddy | Oct 18, 2024
Role of the Technology Transfer Department in the Pharmaceutical Industry The Technology Transfer (TT) department is essential in moving pharmaceutical products from development to full-scale manufacturing. Their primary role is to ensure a seamless transfer of...
by Dr. Yashashwini Reddy | Oct 9, 2024
“Top QMS Interview Questions Every Pharmaceutical Professional Should Know” 1. What is Change Control in QMS? Answer: Change control is a systematic approach used in the pharmaceutical industry to manage any modifications to processes, documentation, or...
by Dr. Yashashwini Reddy | Oct 8, 2024
“Key Responsibilities of the Qualification Department in Pharma” The qualification department plays a key role in the pharmaceutical industry by ensuring that all equipment, processes, and systems are thoroughly tested and validated to meet regulatory and...
