by Dr. Yashashwini Reddy | Aug 27, 2025
1. Contamination Risk Biggest challenge due to microbial, particulate, or endotoxin contamination. Can occur through personnel, raw materials, equipment, environment, or poor aseptic practices. Requires strict aseptic techniques, gowning, and environmental monitoring....
by Dr. Yashashwini Reddy | Aug 27, 2025
HVAC System Validation in Pharmaceuticals A complete guide to compliance, qualification, and best practices for pharmaceutical facilities. 1) Introduction Heating, Ventilation, and Air Conditioning (HVAC) systems in pharmaceutical facilities are critical utilities...
by Dr. Yashashwini Reddy | Aug 18, 2025
📋 Procedure for Sampling in Process Validation 1. Preparation Stage Review the approved Process Validation Protocol for sampling details (points, number of samples, method). Ensure that sampling tools and containers are clean, calibrated, and labeled. Train personnel...
by Dr. Yashashwini Reddy | Aug 18, 2025
Possible Causes of OOS Results 1. Laboratory Errors Improper sample preparation or dilution Incorrect weighing or pipetting Instrument malfunction or improper calibration Wrong method execution or deviation from SOP Calculation or transcription errors 2....
by Dr. Yashashwini Reddy | Aug 18, 2025
✅ Tips to Develop Equipment Cleaning Procedure Risk Assessment First Identify the potential for cross-contamination, product carryover, and microbial risks. Classify equipment as product-contact or non-product-contact. Define Cleaning Scope Clearly specify which...
