by Dr. Yashashwini Reddy | Sep 8, 2025
A Brief Description of the Entire Audit Process in Pharmaceuticals Audits in the pharmaceutical industry are essential for ensuring compliance with cGMP, regulatory requirements, and internal quality standards. They help identify risks, gaps, and opportunities for...
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...
