by Dr. Yashashwini Reddy | Sep 23, 2025
🧪 Case Study: Cross-Contamination in a Multi-Product Pharmaceutical Facility 📌 Background A European pharmaceutical manufacturer operated a multi-product solid oral dosage plant. During a routine EMA inspection, regulatory authorities found traces of a potent API...
by Dr. Yashashwini Reddy | Sep 23, 2025
📝 Case Study: OOS Investigation – Tablet Dissolution 📍 Background A marketed immediate-release tablet showed dissolution failure during routine quality control testing. Specification: NLT (Not Less Than) 80% drug release in 30 minutes. Observed result: 60–65% release...
by Dr. Yashashwini Reddy | Sep 22, 2025
WHO Guidance on Cross-Contamination Definition:Cross-contamination is the unintended presence of one product (or its residues, microbes, cleaning agents, etc.) in another product. Prevention Measures (as per WHO TRS, GMP guidelines): Dedicated facilities or equipment...
by Dr. Yashashwini Reddy | Sep 20, 2025
1. Objective To ensure that equipment, system, or instrument is installed correctly at the user site and performs as per the predefined specifications, operational requirements, and approved protocols. 2. Scope Applicable to all new equipment, utilities, systems, and...
by Dr. Yashashwini Reddy | Sep 16, 2025
1.0 Purpose To establish a procedure for the safe, compliant, and documented disposal of expired finished goods in order to prevent unintended use, ensure environmental safety, and maintain regulatory compliance. 2.0 Scope This SOP applies to all expired, damaged, or...
