This booklet covers the below chapter is taken from PDA's best selling Laboratory Validation,
and offers a complete overview of a specific topic and provides practical advice for anyone interested in current aspects of laboratory validation.Validation of Microbial Identification Systems
There are numerous different technologies available for the characterization and identification of microorganisms. Some companies choose to use the term 'characterization' when the organism is identified to genus, but not necessarily to species and use identification to mean both genus and species. Other systems use gas chromatography. Regardless of the type of system used, the general principles of validation for these systems are consistent. The specific technology employed may require that additional tests be performed. This booklet discusses the general principles for validating these systems and provides examples of protocols for one type of available technology.
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Format: PDF (1 file - 4.08 MB)
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Table of Contents :Accuracy/Precision Testing
II. Qualification of the Identification System
Installation Qualification Testing
IV. Operational Qualification
V. Performance Qualification Testing
Repeatability Testing - Cultures
Repeatability Testing - Analysts
Range of Testing
IX. Appendix B
About the Author
Jeanne Moldenhauer is a Pharma Consultant with
Vectech Pharmaceutical Consultants, Inc. She has over 25 years of experience in
sterile process validation, regulatory affairs, and microbiology. She is an
interest group leader for microbiology and environmental monitoring at PDA,
chair of the Rapid Microbiology User's Group, and a member of the Scientific
Advisory Board of PDA.