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
Impact of Culture and Behaviors on Data Integrity Compliance in Pharmaceuticals Data integrity is not only about systems and SOPs, but also about people’s mindset, culture, and daily behaviors. Even the best electronic systems and QMS can fail if employees lack the...
by Dr. Yashashwini Reddy | Sep 8, 2025
Recent GMP Violations at Indian Pharma Facilities 1. Granules India (Telangana) In a 2024 inspection, the FDA observed severe cross-contamination issues: residues in air ducts, microbial contamination despite HEPA filters, bird droppings and feathers in production...
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...
