by Dr. Yashashwini Reddy | Jun 25, 2025
✅ GVP Module IX – Signal Management 📘 Purpose GVP Module IX provides comprehensive guidance for Marketing Authorisation Holders (MAHs) and regulatory authorities on how to perform signal management, which is a core part of pharmacovigilance. The goal is to ensure...
by Dr. Yashashwini Reddy | Jun 9, 2025
Definition: Self-inspection is a critical component of the pharmaceutical Quality Management System (QMS). It refers to the internal evaluation of all aspects of Good Manufacturing Practices (GMP) within a pharmaceutical facility. The goal is to ensure compliance with...
by Dr. Yashashwini Reddy | May 19, 2025
A Site Acceptance Test (SAT) is a critical phase in the commissioning process of equipment or systems. Conducted at the customer’s site after installation, the SAT verifies that the system operates according to specified requirements in its actual operating...
by Dr. Yashashwini Reddy | May 15, 2025
Standard Operating Procedure (SOP) Here’s a comprehensive Standard Operating Procedure (SOP) for the Calibration of Instruments in Production and Quality Control departments in a pharmaceutical or regulated manufacturing...
by Dr. Yashashwini Reddy | May 6, 2025
Tablet packing machines are essential for the pharmaceutical industry to ensure that tablets are packaged efficiently, safely, and in compliance with regulations. These machines come in various types, depending on the kind of packaging required, such as blister packs,...
