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...
by Dr. Yashashwini Reddy | May 7, 2025
Standard Operating Procedure (SOP) 1. Objective To establish standardized procedures for reprocessing and reworking pharmaceutical products to ensure that all batches meet predefined specifications and maintain product quality. 2. Scope...
