by Dr. Yashashwini Reddy | Sep 10, 2025
🏭 GMP Audit Checklist – Storage of Starting Materials 1. Material Receipt & Identification ✅ Are incoming starting materials received against approved suppliers and purchase orders? ✅ Are materials inspected for damage, tampering, contamination, and labeling...
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
🧾 Common FDA 483 Observations Related to Cleaning in Pharmaceuticals 1. Inadequate Cleaning Validation Cleaning validation not performed for all product-contact equipment. Worst-case product selection (hardest to clean, most toxic/potent, least soluble) not justified....
by Dr. Yashashwini Reddy | Sep 6, 2025
Case Studies: Troubleshooting Purified Water System Failures A Purified Water (PW) System must consistently supply water that meets pharmacopeial standards (USP, EP, IP, JP) for use in manufacturing, cleaning, and testing. Failures in the system can lead to OOS...
by Dr. Yashashwini Reddy | Sep 6, 2025
Regulatory Expectations from Cleaning Validation Cleaning validation is a documented evidence-based process to demonstrate that cleaning procedures effectively and consistently remove residues of products, cleaning agents, and contaminants to predetermined acceptable...
