by Dr. Yashashwini Reddy | Sep 10, 2025
🔎 Major Audit Findings – Equipment & Instruments 1. Qualification & Validation Issues Missing or incomplete DQ/IQ/OQ/PQ records. Equipment used without initial or periodic requalification. Validation protocols not followed or not approved before execution....
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 | Sep 8, 2025
Key Purposes of Change Control in Pharmaceuticals Change control is a critical element of the Quality Management System (QMS) in the pharmaceutical industry. It ensures that all changes affecting processes, equipment, materials, and documents are evaluated,...
by Dr. Yashashwini Reddy | Sep 8, 2025
Data Integrity – A Major Problem in Pharmaceuticals Data integrity has become one of the most critical issues in the pharmaceutical industry, directly impacting patient safety, product quality, and regulatory trust. Regulatory agencies like the FDA, EMA, and MHRA...
by Dr. Yashashwini Reddy | Sep 8, 2025
Drug recalls can harm patients, damage reputation, and lead to regulatory penalties. To minimize risks, pharmaceutical companies should adopt a proactive quality and compliance strategy. 1. Strong Quality Management System (QMS) Implement robust SOPs across...
