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
Certainly! Let’s delve into the detailed distinctions between Process Validation and Product Validation, particularly within the pharmaceutical and medical device industries: Process Validation Definition: Process Validation is the collection and evaluation of...
by Dr. Yashashwini Reddy | May 19, 2025
A Systematic Investigation of Out-of-Specification (OOS) Results in Analytical Testing is a structured approach to identify, evaluate, and resolve instances where test results fall outside predefined specifications. This process is vital in pharmaceutical quality...
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...
by Dr. Yashashwini Reddy | May 13, 2025
Standard Operating Procedure (SOP) Here’s a detailed Standard Operating Procedure (SOP) for the Instrument for Macroscopical Examination, used to visually inspect pharmaceutical products (such as tablets, capsules, and other dosage forms) for...
