by Dr. Yashashwini Reddy | Sep 15, 2025
Critical Mistakes During Root Cause Investigation (RCI) Root Cause Investigation (RCI) is an essential step in pharmaceutical quality systems to identify, analyze, and eliminate the underlying causes of deviations, OOS, failures, or non-conformances. However, many...
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...
by Dr. Yashashwini Reddy | Aug 9, 2025
Improving Quality Through Supplier Audits in Pharmaceuticals 1. Introduction In the pharmaceutical industry, raw materials, packaging components, and outsourced services directly impact the safety, efficacy, and quality of the final product. A supplier audit is a...
by Dr. Yashashwini Reddy | Jun 26, 2025
✅ Pharmacovigilance Audits and Inspections 🔍 1. Pharmacovigilance Audits 📘 Definition: A systematic, independent, and documented process to evaluate the pharmacovigilance (PV) system, its quality system, and compliance with regulatory requirements. 📌...
by Dr. Yashashwini Reddy | Jun 24, 2025
🕵️♀️ GVP Module III – Pharmacovigilance Inspections 🔹 Purpose GVP Module III provides guidance on how pharmacovigilance (PV) inspections are conducted by regulatory authorities in the EU to ensure compliance with PV obligations and to safeguard public health. 🔹 Key...
