by Dr. Yashashwini Reddy | Sep 15, 2025
Major Audit Findings about Equipment and Instruments in Pharmaceuticals Equipment and instruments are critical for ensuring product quality, reliability of test results, and compliance with cGMP. Regulatory inspections (FDA, EMA, MHRA, WHO) often highlight...
by Dr. Yashashwini Reddy | Sep 13, 2025
1. Area & Environment Filling/packaging areas designed to prevent mix-ups and contamination. Environmental conditions (temperature, humidity, differential pressure) monitored. Cleanliness of the area maintained before, during, and after operation. Adequate...
by Dr. Yashashwini Reddy | Sep 9, 2025
🔑 Tips for Effective Internal Audit System Establish Clear Objectives Define the purpose of the audit (compliance, efficiency, risk identification, or process improvement). Develop a Comprehensive Audit Plan Prepare a risk-based annual audit schedule covering all...
by Dr. Yashashwini Reddy | Sep 8, 2025
Planning and Execution of Internal Audits in Pharmaceuticals Internal audits (self-inspections) are a key part of a pharmaceutical Quality Management System (QMS). They ensure compliance with cGMP, regulatory guidelines, and company SOPs, while also driving continuous...
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...
