by Dr. Yashashwini Reddy | Aug 9, 2025
Out of Specification (OOS) Investigation in Pharmaceuticals Definition OOS results are test results that fall outside the pre-established acceptance criteria defined in specifications, procedures, or regulatory filings.They can occur in raw materials, in-process...
by Dr. Yashashwini Reddy | Aug 9, 2025
GMP Requirements in Pharmaceuticals Good Manufacturing Practice (GMP) is a regulatory framework ensuring that pharmaceutical products are consistently produced and controlled according to quality standards, minimizing risks to patients. 1. Quality Management System...
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 —...
