This chapter is taken from the book Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume 2

No industry's products more intuitively illustrate the importance of product quality than those produced by pharmaceutical manufacturers.

Quality managers are especially effective when a commitment to continual improvement is shared throughout the organization. The recent noteworthy movement toward industrial modernization has included a realization that opportunities for updating manufacturing and laboratory technologies are abundant, and a strong Quality System will provide the accompanying infrastructure in which to drive this emerging renaissance. This modernization trend intertwines with the Quality System by emphasizing an improved product development paradigm; technological advances in production, monitoring and control; and systematic methods for managing risk.

This chapter addresses the "top twenty" features of a well-managed Quality System, from this author's CGMP perspective. Each of the features is integral to an effective Quality System, and the presence or absence of any one can be revealing with respect to an organization's quality philosophy and culture. Some concepts discussed, including needed improvements in microbiology laboratory methods development and analyst qualification, will benefit from further articulation by industry and regulatory agencies in the coming years.

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About the Authors

Richard L. Friedman is the Director of the Division of Manufacturing & Product Quality in the Center for Drug Evaluation and Research (CDER). In this position, he directs the interpretation and development of CGMP policy, review of inspectional recommendations, and determination of manufacturing site acceptability. He has been employed by FDA since 1990, including prior positions as New Jersey District Drug Specialist, CDER Senior Compliance Officer, and Team Leader of Guidance and Policy. Mr. Friedman has authored several publications on topics including sterile drugs and quality management systems, and was awarded The George M. Sykes Award by the Parenteral Society for outstanding journal paper for the year 2005. Mr. Friedman is also an adjunct faculty member of Temple University School of Pharmacy in their QA/RA graduate program. Prior to joining FDA, Mr. Friedman worked in the toxicology research division of an innovator pharmaceutical company. Mr. Friedman received his B.S. in Biology with honors from Montclair State University in 1989 and his M.S. in Microbiology from Georgetown University School of Medicine in May, 2001.