by Dr. Yashashwini Reddy | Nov 1, 2024
Understanding Why-Why Analysis in Pharmaceuticals: Uncovering the Root of Quality Issues The Why-Why analysis, or “5 Whys,” is a structured root cause analysis method widely used in the pharmaceutical industry to identify and resolve issues at their...
by Dr. Yashashwini Reddy | May 28, 2024
Departure from an approved procedure, instruction, or documented procedure is called deviation. A deviation should be properly documented and handled. A deviation can occur during the manufacturing, testing, storage, or distribution of pharmaceuticals. Deviations most...
by Dr. Yashashwini Reddy | May 3, 2024
Identifying the root cause of the problem is very important. In pharmaceuticals Root cause analysis is an invaluable tool to dig deep and identify the origin of the problem. To perform Root cause analysis, different techniques are used. that I’m going to mention...