by Dr. Yashashwini Reddy | Sep 8, 2025
Key Purposes of Change Control in Pharmaceuticals Change control is a critical element of the Quality Management System (QMS) in the pharmaceutical industry. It ensures that all changes affecting processes, equipment, materials, and documents are evaluated,...
by Dr. Yashashwini Reddy | Aug 27, 2025
HVAC System Validation in Pharmaceuticals A complete guide to compliance, qualification, and best practices for pharmaceutical facilities. 1) Introduction Heating, Ventilation, and Air Conditioning (HVAC) systems in pharmaceutical facilities are critical utilities...
by Dr. Yashashwini Reddy | Aug 18, 2025
FDA Requirements for Training in Pharmaceuticals The U.S. Food and Drug Administration (FDA), under 21 CFR Part 211 (cGMP for Finished Pharmaceuticals) and ICH Q10 Pharmaceutical Quality System, outlines clear expectations for employee training. 1. Training Program...
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 | Apr 29, 2025
Pharmaceutical compliance plays a crucial role in ensuring the overall quality of medicinal products. Compliance in the pharmaceutical industry refers to adherence to regulations, laws, and guidelines set by governing bodies such as the U.S. Food and Drug...
