by Dr. Yashashwini Reddy | Sep 8, 2025
Planning and Execution of Internal Audits in Pharmaceuticals Internal audits (self-inspections) are a key part of a pharmaceutical Quality Management System (QMS). They ensure compliance with cGMP, regulatory guidelines, and company SOPs, while also driving continuous...
by Dr. Yashashwini Reddy | Sep 8, 2025
A Brief Description of the Entire Audit Process in Pharmaceuticals Audits in the pharmaceutical industry are essential for ensuring compliance with cGMP, regulatory requirements, and internal quality standards. They help identify risks, gaps, and opportunities for...
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 | 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
Data Integrity – A Major Problem in Pharmaceuticals Data integrity has become one of the most critical issues in the pharmaceutical industry, directly impacting patient safety, product quality, and regulatory trust. Regulatory agencies like the FDA, EMA, and MHRA...
