Table of contents - GMP-Verlag
Table of contents - GMP-Verlag
Table of contents - GMP-Verlag
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ContentsixATP Analysis for Non-sterile Pharmaceuticals 201Feasibility Studies 201Examining the Microbial Status <strong>of</strong> Products to be Tested 203Examining the Product Formulations for MicrobialContamination Sources 204Examining the Product Formulations for Sources <strong>of</strong> ATP 204Examining the Products for Materials that Interfere withATP Analysis 204Examining the Products for Materials that Quench the LightEmitted During Analysis 204Practical Application <strong>of</strong> ATP Analysis 205Estimating Microbial Numbers by ATP Analysis 206Result Interpretation from ATP Analysis 207All Samples are Negative 207The Largest Sample Aliquot is Positive and All OtherAliquots are Negative 207More Than One Sample Aliquot is Positive 208Choice <strong>of</strong> Culture Media 208Media Quality Control 209Selection <strong>of</strong> Test Cultures 210Preparation <strong>of</strong> Cultures for Validation Testing 210Validation <strong>of</strong> Testing Methods 212Sample Testing Strategies Using ATP Analysis 213Sample Testing Scheme EP 214Sample Testing Scheme USP 214Sample Testing Scheme Harmonized 214Choosing a Testing Scheme for ATP Analysis Validation 215Validation Principles for Compendial Tests 216ATP Analysis Methods 217Incubation Requirements for Samples 218Validation Testing Schemes 224Validation Result Interpretation 228Practical Application <strong>of</strong> ATP Analysis 229Conclusions 231References 232About the Author 232www.pda.org/bookstore
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