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 8, 2025
6 Ways to Reduce Human Errors in Pharmaceuticals Human error is one of the leading causes of deviations, batch failures, and regulatory findings in the pharmaceutical industry. A proactive approach can significantly minimize mistakes and improve compliance. 1....
by Dr. Yashashwini Reddy | Sep 8, 2025
Drug recalls can harm patients, damage reputation, and lead to regulatory penalties. To minimize risks, pharmaceutical companies should adopt a proactive quality and compliance strategy. 1. Strong Quality Management System (QMS) Implement robust SOPs across...
by Dr. Yashashwini Reddy | Sep 6, 2025
Planning and Procedure Followed During Regulatory Audits Regulatory audits (by USFDA, EMA, MHRA, WHO, or local authorities) are conducted to verify compliance with cGMP and regulatory standards. Effective preparation and systematic execution are crucial for success....
by Dr. Yashashwini Reddy | Sep 6, 2025
Data Falsification in the Pharmaceutical Industry 1. What is Data Falsification? Data falsification in pharmaceuticals refers to the intentional manipulation, fabrication, or misrepresentation of data in order to conceal deviations, meet specifications, or mislead...
