Investigator Abuzar Shamim takes a comprehensive approach in his audits, giving equal importance to aseptic process validation, cleanliness and sterilization practices, environmental monitoring, stability testing, and container closure integrity testing. He is particularly vigilant about the need for adequate documentation to support the validation of key processes.

FDA Investigator Abuzar Shamim leans towards a strong emphasis on aseptic processing validation and proper adherence of cleaning, sanitizing, and sterility practices. He emphasizes the importance of proper documentation to affirm sterilization validation, environmental monitoring and gowning and hand washing practices. Furthermore, he scrutinizes container closure integrity, stability testing program, and sterility and pyrogen testing.