The manufacture of sterile drug and biotechnology products technologically represents the hardest challenge for the pharmaceutical manufacturer to perform correctly. There is no margin for error – a contaminated product can kill the patient. The challenge for the pharmaceutical and biotechnology industries is to design the facility, equipment and processes to prevent the ingress of microbial contaminants, to ensure people know that they are the largest source of product contamination and how their behavior has direct impact on product safety, and to build systems that guarantee products made are sterile.
This course discusses the practical implementation of GMPs in facility and equipment design and in process design and operations. You will leave with an understanding of the regulatory expectations for equipment and utility qualification and sterile process validation in order to assure that the products manufactured are proof-positive sterile.