Pharmaceutical Microbiology Laboratories Proficiency and Competency (single user digital version)

Aug 2009
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This chapter is taken from the book Environmental Monitoring: A Comprehensive Handbook, Volume 3

A literature search will reveal that laboratory proficiency testing and personnel competency testing have been integral elements of formal microbiology quality assurance programs in most microbiology testing disciplines. Recently, while serving in the capacity of Director of Product and Market Development for a commercial company dedicated to the manufacture, sales and distribution of preserved microorganism preparations, this author experienced an increased volume of inquiries originating from pharmaceutical microbiology laboratories performing USP microbiology test methods. The inquiries were about the availability of programs and microorganism challenge samples for proficiency or competency testing.

The initial inquiries prompted a simple survey during early 2007. This survey was designed to only collect basic information and was not intended to be a statistical sampling. Approximately 50 major pharmaceutical and biotechnology laboratories in the USA and Europe were interviewed. The list of questions included in the survey is provided in Appendix.

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Table of Contents

Table of Contents:

  • Introduction to Proficiency and Competency
  • Elements of Analyst Competency Assessment
  • Competency Assessment Samples
  • Conducting an Analyst Competency Assessment
  • Summary
  • References
  • Appendix I: Proficiency and Competency Survey Form
  • Appendix II: Analyst Competency Assessment Checklist
  • About the Authors

    About the Authors

    Jerry Tjernagel's academic achievements and experience have servd him for 40 years in a microbiology career. Prior to retirement, for a period of 25 years, Jerry was the Director of Product and Market Development for MicroBioLogics, Inc. His responsibilities included the development of microorganism preparation products for use as quality assurance, quality control and proficiency testing challenges in clinical and industrial microbiology laboratories.
    Prior to his employment at MicroBioLogics, Jerry was the Director of Clinical Microbiology at a large regional hospital. His responsibilities also included continuing education, development of test methods, quality assurance and quality control in several hundred hopsital and clinic microbiology laboratories.