File : pdf, 516 KB, 128 pages
TOC
Chapter 1. Introduction
Opening Remarks
Scope and Limitations of Performance-Based Data Review
Performance-Based Data Review Versus Data Validation
Performance-Based Data Review Versus Usability Assessment
Overview of Performance-Based Data
Chapter 2. Data Review Reports
Introduction
Data Summary Tables
Project Specific Communications
Chapter 3. Data Qualifiers
Introduction
Definitions of Data Qualifiers
Chapter 4. Completeness
Introduction Minimum Reporting Requirements
Cover Letter
Case Narrative Sample Management Records Batch QC Summary Results Standard Preparation Logs
Sample Preparation Logs
Instrument Run-Sequence Logs Traceability
Calibration Summary Chromatographic Methods for Organic Target Analytes Initial Calibration
Internal Standard Summary Information Surrogate Results Chromatographic Methods With 2-D
Detectors
Evaluation of Completeness Missing Blanks Missing Laboratory Control Matrix Spike Data Surrogate
Spike Data
CCV Data Missing Detection Limits
Chapter 5. Holding Times and Preservation
Introduction Acceptance Criteria EvaluationLow Stability Target Analytes
High Stability Target
Chapter 6. Data Review Reports
Introduction Method Reporting Limits Establishing Method Reporting Limits Qualification
Method Quantitation Limits Establishing Method Quantitation Limits Qualification
Chapter 7. Initial Calibration
Number of Calibration Standards
Linear Calibration
Organic Methods Inorganic Methods
Nonlinear Calibration Intercept of Calibration Curve
Evaluation
“Goodness of Fit”
Representativeness of Initial Calibration Curve
Qualification
Frequency and Number of Standards Representativeness “Goodness of Fit”
Calibration Range
Chapter 8. Initial Calibration Verification (ICV)
Introduction Criteria
Evaluation
Qualification
Frequency Percent Recovery
Inorganics Organics
Qualification for Bias
Chapter 9. Continuing Calibration Verification (CCV)
Introduction Criteria
Traceability and Reporting Requirements
Representativeness Chromatographic Methods Organic Chromatographic Methods Tolerance for
Uncertainty
Inorganic Methods, CCVs Not Processed with Samples Inorganic Methods, CCVs Processed with Samples
Organic Methods, CCVs Not Processed with Samples
Organic Methods, CCVs Processed with Samples
General Qualification Strategies
Chapter 10. Blanks
Chapter 11. Laboratory Control Samples (LCSs)
Chapter 12. Matrix Spikes, Matrix Spike Duplicates, and Matrix Duplicates
Interpretation of Matrix Spike and Duplicate Results Estimating Statistical Matrix Spike Recovery
Ranges Criteria
Representativeness Frequency Acceptance Limits
Project Specific Communications Establishing Acceptance Limits for Matrix-Dependent Duplicates
Evaluation
Contractual Considerations Qualification
Matrix Spikes and Matrix Spike Duplicates
Matrix-Dependent Duplicates
Chapter 13. Surrogates
Chapter 14. Data Review Reports
Chapter 15. Data Review Reports
Chapter 16. Internal Standards for Organic Chromatographic Methods
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