by Dr. Yashashwini Reddy | Apr 28, 2025
Introduction Quality is a cornerstone of the pharmaceutical industry because it directly affects patient safety, therapeutic effectiveness, and public trust. When we talk about “quality standards,” we refer to the strict guidelines, procedures, and...
by Dr. Yashashwini Reddy | Apr 26, 2025
Standard Operating Procedure (SOP) 1. Purpose To outline the procedure for investigating failures in processes, systems, products, or equipment to determine root causes, implement corrective actions, and prevent recurrence. 2. Scope This SOP...
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 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 | Oct 22, 2024
Quality by Design (QbD) in Pharmaceuticals: Enhancing Drug Development and Manufacturing In the pharmaceutical industry, ensuring product quality is crucial to patient safety and regulatory compliance. Quality by Design (QbD) is a systematic approach to drug...
