by Dr. Yashashwini Reddy | Aug 29, 2025
1. Purpose To describe the procedure for performing microbiological integrity testing of sealed vials to ensure container closure integrity and sterility assurance. 2. Scope This SOP applies to all finished sterile product vials manufactured in the facility that...
by Dr. Yashashwini Reddy | Aug 28, 2025
1.0 Purpose To define the procedure for the preparation of disinfectant solutions used in pharmaceutical/biotechnology facilities for cleaning and sanitization purposes. 2.0 Scope This SOP applies to all personnel involved in the preparation, dilution, and labeling of...
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
✅ 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...
by Dr. Yashashwini Reddy | Aug 18, 2025
Self-Inspection and Its Implementation in Pharmaceuticals Definition:Self-inspection is a systematic, independent, and documented internal audit conducted by a pharmaceutical company to evaluate compliance with Good Manufacturing Practices (GMP), regulatory...
