by Dr. Yashashwini Reddy | Sep 11, 2025
📌 Current Good Manufacturing Practices (cGMP) in Pharmaceutical Industries Definition:cGMP (Current Good Manufacturing Practices) are the regulations enforced by regulatory authorities (like US FDA, EMA, WHO, MHRA, CDSCO, etc.) to ensure that pharmaceutical products...
by Dr. Yashashwini Reddy | Sep 6, 2025
Requirements of FDA for Training in Pharmaceuticals Training in the pharmaceutical industry is a critical requirement under cGMP regulations (21 CFR Parts 210 & 211). The FDA expects companies to have a structured, documented training system that ensures employees...
by Dr. Yashashwini Reddy | Sep 6, 2025
10 Step Guide to cGMP Certification cGMP (Current Good Manufacturing Practices) certification demonstrates that a company’s facilities, processes, and quality systems comply with international regulatory standards (FDA, EMA, WHO, PIC/S). It assures product quality,...
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 | May 8, 2025
Standard Operating Procedure (SOP) 1.0 OBJECTIVE To establish a standardized procedure for cleaning the drum mixer to maintain product quality, ensure hygiene, prevent cross-contamination, and comply with safety and regulatory standards. 2.0...
