by Dr. Yashashwini Reddy | Apr 11, 2025
Isn’t it amazing to be alive right now? We have answers to almost any question at our fingertips, thanks to the tiny device we carry in our hands. However, even with all these incredible resources, things don’t always go as planned, and we still face...
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 11, 2024
Fishbone Diagram in the Pharmaceutical Industry: A Simple Guide Creating a Fishbone Diagram, also known as an Ishikawa or Cause-and-Effect Diagram, is a great way to visually break down and understand the causes of a problem in pharmaceutical processes. This tool is...
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...
