Table of contents - GMP-Verlag
Table of contents - GMP-Verlag
Table of contents - GMP-Verlag
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ContentsxiiiValidation <strong>of</strong> Analytical Parameters 321Accuracy 323Linearity 324Precision 325Range 327Limit <strong>of</strong> Detection and Quantitation 328Specificity 331Ruggedness and Robustness 331Equivalency - Purified Water Analysis 331Summary and Conclusion 334References 335About the Authors 33814. Validation <strong>of</strong> the ScanRDI® for Microbial Detectionin Mammalian Cell Culture Systems 339Amy McDanielIntroduction and Purpose 339Principle <strong>of</strong> the Method 340Master Plan Overview 342Instrument Qualification Summary 343Method Validation Summary 343Method Evaluation 344Concurrent Testing 346Example <strong>of</strong> ScanRDI® Usefulness in Contamination Detection 349Method Validation 350Limit <strong>of</strong> Detection 351Specificity 352Robustness 352Ruggedness (Intermediate Precision) 353Crossover Studies 354Conclusion 355Acknowledgements 355References 356About the Author 356www.pda.org/bookstore
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