Modern Quality Systems (single user digital version)

Feb 2008
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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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Table of Contents

Table of Contents:

  • Introduction
    1. Global Quality Assurance
    2. Quality Foundation
    3. Good Science
    4. Intended Use
    5. People: Qualifications, Roles, Responsibilities
    6. Reliable Laboratory
    7. Suitability of Equipment, Facilities, and Associated Procedures
    8. Raw Material Quality and Surveillance
    9. Batch Review and Release
    10. Documentation
    11. Effective Development and Process Validation
    12. "Building Quality In" and the Willingness to Fix a Flawed Process
    13. Effective Use of Risk Assessment
    14. Understanding Sources of Variability and Signals of Drift
    15. Awareness of the Link Between Safety, Efficacy, and Quality
    16. The Quality Organization: Authority, Responsibility, and Accountability
    17. Taking Action When Necessary
    18. Internal Audit Program
    19. Contracting and Outsourcing Scrutiny
    20. Modernization: Knowing the Current Science and Employing Contemporary Technology
  • Conclusion
  • References
  • About the Authors

    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.