by Dr. Yashashwini Reddy | Aug 9, 2025
Different Types of HPLC Detectors 1. UV/Vis Absorbance Detector Principle: Measures absorbance of analytes at a specific wavelength (Beer-Lambert Law). Types: Fixed Wavelength UV (e.g., 254 nm) Variable Wavelength UV Diode Array Detector (DAD/PDA) – allows spectral...
by Dr. Yashashwini Reddy | Aug 9, 2025
4 Steps to Effective Change Control in Pharmaceuticals 1. Initiation & Documentation Identify the need for change (equipment, process, material, method, etc.). Document the proposed change in a Change Control Form with details like scope, reason, impact area, and...
by Dr. Yashashwini Reddy | Aug 8, 2025
What Quality Really Means for Pharmaceuticals In the pharmaceutical industry, quality means ensuring that every medicine is safe, effective, and consistent, from raw materials to the final product delivered to patients. It is not just about meeting specifications —...
by Dr. Yashashwini Reddy | Aug 8, 2025
Possible Causes of Out of Specification (OOS) Results OOS results occur when the test results fall outside the predefined acceptance criteria or specification limits. Causes can be grouped into three main categories: 1. Laboratory Errors Instrumental issues:...
by Dr. Yashashwini Reddy | Aug 8, 2025
Why Analytical Method Validation is Required? Analytical Method Validation is essential to ensure that a test method is reliable, reproducible, and suitable for its intended purpose.It is required because: Regulatory Compliance Required by ICH Q2(R1), USFDA, EMA, and...
