by Dr. Yashashwini Reddy | Aug 28, 2025
1.0 Purpose To establish a standard procedure for the routine cleaning and disinfection of the sterile dress cabinet to ensure aseptic conditions are maintained for storage of sterile garments. 2.0 Scope This SOP applies to all sterile dress cabinets located in...
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
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...