by Dr. Yashashwini Reddy | Jun 18, 2025
Here’s a complete view of pharmacovigilance—a structured, end‑to‑end journey that ensures drug safety from lab to real-world use: 1. Definition & Scope Pharmacovigilance (PV) is the science and set of processes for detecting, assessing, understanding, and...
by Dr. Yashashwini Reddy | May 1, 2025
Quality by Design (QbD) in Pharmaceuticals: A Detailed Explanation Quality by Design (QbD) is a systematic approach to pharmaceutical development that aims to ensure the quality of a drug product through the design and control of the manufacturing process. This...
by Dr. Yashashwini Reddy | Apr 29, 2025
Supplier audits have a significant and multifaceted impact on quality assurance in the pharmaceutical sector. Here’s a detailed breakdown of their influence: 1. Ensuring Compliance with Regulatory Standards Supplier audits help ensure that raw material...
by Dr. Yashashwini Reddy | Apr 27, 2025
Standard Operating Procedure (SOP) 1. Purpose The purpose of this SOP is to provide guidelines for the identification, handling, storage, and disposal of prohibited items within [Organization/Department Name], ensuring compliance with...
by Dr. Yashashwini Reddy | Apr 26, 2025
Standard Operating Procedure (SOP) 1. Purpose To outline the procedure for investigating failures in processes, systems, products, or equipment to determine root causes, implement corrective actions, and prevent recurrence. 2. Scope This SOP...
