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 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 | 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 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 4, 2024
Whenever there is a need to address quality-related issues CAPA is initiated, examples of quality-related issues include deviations, non-conformances, market complaints, deficiency during internal audits, product recalls, etc. CAPA aims to address the issue in such a...
