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 15, 2025
Standard Operating Procedure (SOP) Here’s a detailed Standard Operating Procedure (SOP) for Discipline in the Manufacturing Area, intended to ensure GMP compliance, product safety, and a professional working environment. 1....
by Dr. Yashashwini Reddy | May 15, 2025
Standard Operating Procedure (SOP) Here’s a comprehensive Standard Operating Procedure (SOP) for the Cleaning and Maintenance of a Fogger, typically used in pharmaceutical manufacturing for disinfection purposes. 1. Purpose...
