by Dr. Yashashwini Reddy | Aug 18, 2025
Self-Inspection and Its Implementation in Pharmaceuticals Definition:Self-inspection is a systematic, independent, and documented internal audit conducted by a pharmaceutical company to evaluate compliance with Good Manufacturing Practices (GMP), regulatory...
by Dr. Yashashwini Reddy | Jun 24, 2025
⚠️ GVP Module V – Risk Management Systems 🔹 Purpose GVP Module V provides guidance on the establishment, implementation, and maintenance of Risk Management Systems (RMS) to ensure proactive identification, characterization, prevention, or...
by Dr. Yashashwini Reddy | May 6, 2025
Here’s a detailed checklist for auditing an ointment manufacturing facility, aligned with Good Manufacturing Practices (GMP), regulatory expectations (such as USFDA, WHO, EU-GMP), and quality standards. The checklist is categorized for clarity: 1. General...
