by Naveen kumar | 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 Naveen kumar | 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 Naveen kumar | 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 Naveen kumar | 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 Naveen kumar | 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...
