by Dr. Yashashwini Reddy | Aug 28, 2025
1.0 Purpose To describe the standard procedure for the safe and effective operation of the Fogster-ULV (Ultra-Low Volume) Fogger Machine for disinfection of classified and controlled areas in the facility. 2.0 Scope This SOP applies to all trained personnel...
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 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
Writing Effective SOPs in Pharmaceuticals Standard Operating Procedures (SOPs) are the backbone of pharmaceutical operations, ensuring consistency, compliance, and quality across all processes. An effective SOP must be clear, concise, and compliant with GMP (Good...
by Dr. Yashashwini Reddy | Aug 18, 2025
Revalidation of Pharmaceutical Processes Revalidation in pharmaceuticals refers to the documented evidence that an established process continues to operate in a state of control and consistently produces a product meeting predetermined specifications and quality...
