Table of contents - GMP-Verlag

ContentsvProblems with Species Not in the Database 62Retrospective Trending 63Validation of Identification Systems 63Perspectives on Phenotypic ID Versus DNA-based ID 64The Basic Steps of Phenotypic Testing 65The Importance of Standardization and Precisionin the Testing Regime 66Isolation of a Pure Culture 66Cultivation on Appropriate Agar Media 67Performance of the Gram Stain 68Selection of the Appropriate Test Panel 69Preparation of the Inoculum 69Inoculation of the Panel 70Incubation of the Panel 70Reading and Interpretation of the Results 70Conclusions and the Future of Phenotypic Testing 71References 72About the Author 734. Under the Microscope: Microbial Identifications inPharmaceutical and Biopharmaceutical Quality ControlLaboratories, “An Era of Coarse to Fine Adjustment” 75Mary Griffin and Dona ReberRegulatory Considerations 75Methods 78Validation 84Looking Ahead 85Case Study 85Met Assay Acceptance Criteria 87Accepted Identification 87Results and Discussion 88Current Example of a Process Flow Approachfor Identification 92www.pda.org/bookstore