by Dr. Yashashwini Reddy | Sep 10, 2025
✅ 4 Tips to Reduce 483 Observations 1. Strengthen Documentation Practices Ensure records are contemporaneous, complete, and accurate (ALCOA+ principles). Use controlled logbooks, proper version control, and audit trails. Train staff to document activities at the time...
by Dr. Yashashwini Reddy | Sep 10, 2025
🔴 Critical Mistakes in Root Cause Investigation (RCI): Jumping to Conclusions – Assuming the cause without evidence or proper investigation. Superficial Investigation – Stopping at symptoms instead of identifying the true underlying cause. Poor Documentation –...
by Dr. Yashashwini Reddy | Sep 9, 2025
⚠️ 5 Most Common FDA 483 Observations in Pharma 1. Inadequate Investigations (OOS / Deviations / Complaints) Failure to thoroughly investigate out-of-specification (OOS) results, deviations, or complaints. Root cause analysis either incomplete, unjustified, or not...
by Dr. Yashashwini Reddy | Sep 9, 2025
🔐 Why Data Integrity is More Important Than Ever? 1. Patient Safety at the Core Medicines are only as safe as the data proving their quality. Any falsified, incomplete, or inaccurate record may lead to unsafe products reaching patients. Strong data integrity ensures...
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...
