The role of microbiologists in pharmaceutical development and manufacturing has become more visible in recent years due to the QbD and risk-based approaches promoted by regulatory authorities and industry [i]. Microbiology, microbiological control and contamination control are indispensable in the manufacture of sterile and nonsterile products as well as biologic drug substances, as evidenced by multiple conference presentations and publications. Terms such as objectionable microorganisms, organisms of concern, alert and action limits, environmental monitoring and sterility are dominating our daily work. Lack of sterility assurance is the number one reason for recalls of sterile drug products, and presence of objectionable organisms is the number one reason for recalls of nonsterile products [2,3]. While no one disputes the role of microbiologists in the design and development of pharmaceutical manufacturing processes, microbiologists still appear 'confined' in the laboratory of the manufacturing facility long after a process has been established and approved.
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