by Dr. Yashashwini Reddy | Aug 12, 2025
Sampling and Testing in Exhibit and Process Validation Batches 1. Introduction Exhibit Batches: Produced at commercial scale (or pilot scale in some cases) before product launch, used to demonstrate manufacturing feasibility and generate stability, quality, and...
by Dr. Yashashwini Reddy | Aug 12, 2025
Quality Management System (QMS) 1. Definition A Quality Management System (QMS) is a structured framework of policies, procedures, processes, and resources that ensures pharmaceutical products consistently meet quality, safety, efficacy, and regulatory requirements.It...
by Dr. Yashashwini Reddy | Aug 12, 2025
Aspect Process Validation Product Validation Definition Documented evidence that a manufacturing process, operated within established parameters, can consistently produce a product meeting its predetermined quality attributes. Documented evidence that a specific...
by Dr. Yashashwini Reddy | Aug 12, 2025
Gemba Walks and Their Implementation in Pharmaceuticals 1. What is a Gemba Walk? Gemba is a Japanese term meaning “the real place”—where work actually happens. In lean manufacturing and quality management, a Gemba Walk is when leaders, managers, or QA personnel go to...
by Dr. Yashashwini Reddy | Aug 12, 2025
CAPA Documentation: Common Mistakes to Avoid Definition:Corrective and Preventive Actions (CAPA) are processes used in pharmaceutical quality systems to investigate, address, and prevent the recurrence of deviations, non-conformances, or quality issues. Proper...
