by Dr. Yashashwini Reddy | Jun 18, 2025
🧠 What Is Pharmacovigilance? Pharmacovigilance (PV) is the science and activities aimed at detecting, assessing, understanding, and preventing adverse effects or any other drug‑related issues once a medicine is in use . The term originates from the Greek pharmakon...
by Dr. Yashashwini Reddy | Jun 9, 2025
Importance of Validation in Pharmaceuticals Validation in the pharmaceutical industry is a documented process that proves that a system, equipment, method, or process consistently produces a result meeting predetermined quality standards. It is a fundamental part of...
by Dr. Yashashwini Reddy | Jun 9, 2025
Cleaning Validation Procedure for Clean-in-Place (CIP) Systems Purpose:To establish and document a systematic approach ensuring that the Clean-in-Place (CIP) system effectively cleans equipment and piping without manual disassembly, preventing cross-contamination and...
by Dr. Yashashwini Reddy | Jun 9, 2025
Validation of Compressed Air frame 1. Introduction Importance of compressed air in pharmaceutical manufacturing. Regulatory expectations (e.g., EU GMP Annex 1, ISO 8573, WHO guidelines). Role of compressed air in cleanroom environments, product...
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...
