by Dr. Yashashwini Reddy | Aug 18, 2025
FDA Warning Letters for Cleaning Validation The FDA frequently issues Warning Letters to pharmaceutical manufacturers for deficiencies in cleaning validation programs, as inadequate cleaning can lead to cross-contamination, adulteration, and patient safety risks....
by Dr. Yashashwini Reddy | Aug 12, 2025
Quality Management System (QMS) 1. Definition A Quality Management System (QMS) is a structured framework of policies, procedures, processes, and resources that ensures pharmaceutical products consistently meet quality, safety, efficacy, and regulatory requirements.It...
by Dr. Yashashwini Reddy | Aug 11, 2025
Calibration of Friability Test Apparatus 1. Introduction The friability test determines the ability of uncoated tablets to resist mechanical stress during handling, packaging, and transportation. The friability test apparatus (e.g., Roche Fryolator) rotates tablets in...
by Dr. Yashashwini Reddy | Aug 11, 2025
UV Cabinet Calibration in Pharmaceuticals 1. Introduction A UV Cabinet (also called a UV viewing cabinet or UV inspection chamber) is used in pharmaceutical laboratories for visual inspection of materials—especially for thin-layer chromatography (TLC) plates,...
by Dr. Yashashwini Reddy | Aug 11, 2025
Calibration of Refractometer 1. Introduction A refractometer is used in pharmaceutical, food, and chemical industries to measure the refractive index (RI) of liquids, which is related to concentration or purity. Calibration ensures measurement accuracy and compliance...