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 1, 2025
🌍 What is a Gemba Walk? Gemba is a Japanese term meaning “the real place” — where the actual work happens. In pharmaceuticals, the Gemba is the production floor, laboratory, warehouse, QC lab, cleanroom, or sterile area where processes are executed. A Gemba Walk is...
by Dr. Yashashwini Reddy | Aug 10, 2025
Requirements and Implementation of Continuous Training in Pharmaceuticals Continuous training in the pharmaceutical industry is a regulatory, quality, and operational necessity to ensure that employees remain competent, compliant, and up-to-date with evolving...
by Dr. Yashashwini Reddy | May 19, 2025
A Quality Management System (QMS) is a structured framework comprising processes, procedures, and responsibilities aimed at consistently delivering products or services that meet customer expectations and regulatory requirements. It serves as the backbone of an...
by Dr. Yashashwini Reddy | May 19, 2025
Gemba Walks, a cornerstone of Lean Management, are instrumental in enhancing operational efficiency and quality in pharmaceutical manufacturing. By observing processes directly on the production floor, organizations can identify inefficiencies, engage...
