Regulated Bioanalytical Laboratories

Name: Regulated Bioanalytical Laboratories | Technical and Regulatory Aspects from Global Perspectives
Brand: Wiley
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Technical and Regulatory Aspects from Global Perspectives

Michael Zhou(Autor*in)

Wiley (Verlag)

Erschienen am 4. November 2010

528 Seiten

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REGULATED BIOANALYTICAL LABORATORIES: Technical and Regulatory Aspects from Global Perspectives
CONTENTS
PREFACE
ACKNOWLEDGMENT
CONTRIBUTORS AND ADVISORS
1 INTRODUCTION, OBJECTIVES, AND KEY REQUIREMENTS FOR GLP REGULATIONS
1.1 INTRODUCTION
1.1.1 Good Laboratory Practices
1.1.2 Bioanalytical Laboratories-Bioanalysis
1.1.3 Good Laboratory Practices Versus Bioanalytical Labs/Bioanalysis
1.2 OBJECTIVES AND KEY REQUIREMENTS FOR GLP REGULATIONS
1.3 FUNDAMENTAL UNDERSTANDING OF GLP REGULATIONS AND PRINCIPLES
1.3.1 Elements of Good Laboratory Practices
1.4 KEY ELEMENTS OF BIOANALYTICAL METHODS VALIDATION
1.4.1 Reference Standards
1.4.2 Method Development-Chemical/Chromatographic Assay
1.4.3 Calibration/Standard Curve
1.4.4 Stability
1.4.5 Reproducibility
1.4.6 Robustness or Ruggedness
1.5 BASIC PRINCIPLES OF BIOANALYTICAL METHOD VALIDATION AND ESTABLISHMENT
1.5.1 Specific Recommendations for Method Validation
1.5.2 Acceptance Criteria for Analytical Run
REFERENCES
2 HISTORIC PERSPECTIVES OF GLP REGULATIONS, APPLICABILITY, AND RELATION TO OTHER REGULATIONS
2.1 HISTORIC PERSPECTIVES OF GLP REGULATIONS
2.1.1 Economic Assessment
2.1.2 Environmental Impact
2.2 APPLICABILITY AND RELATIONS TO OTHER REGULATIONS/ PRINCIPLES
2.2.1 GLP, GCP, GMP, and Part 11
2.2.2 General Terminologies and Definitions of GxPs (GLP, GCP, and cGMP)
2.3 COMPARISON OF FDA GLP, EPA GLP REGULATIONS, AND OECD GLP PRINCIPLES
2.3.1 US and OECD GLP Similarity and Differences
2.4 APPLICATIONS OF GLP TO MULTIPLE SITE STUDIES
2.4.1 Roles and Responsibilities
2.4.2 Performance of the Studies
2.4.3 Applications of GLP to In Vitro Studies for Regulatory Submissions
2.5 21 CFR PART 11 IN RELATION TO GLP PROGRAMS
2.5.1 A New Risk-Based Approach
2.5.2 Understanding Predicate Rule Requirements
2.5.3 21 CFR Part 11 Best Practices
2.5.4 Use of Electronic Signatures
2.6 GLP, cGMP, AND ISO APPLICABILITIES, SIMILARITY, AND DIFFERENCES
2.6.1 GLPs, cGMPs, ISO 17025:2005: How Do They Differ?
2.6.2 GLPs Versus GMPs
2.6.3 GLPs Versus ISO/IEC 17025:2005
2.6.4 ISO Versus GLPs
2.7 GOOD CLINICAL PRACTICES AND GOOD CLINICAL LABORATORY PRACTICES
2.8 GAP AND CURRENT INITIATIVES ON REGULATING LABORATORY ANALYSIS IN SUPPORT OF CLINICAL TRIALS
REFERENCES
3 GLP QUALITY SYSTEM AND IMPLEMENTATION
3.1 GLP QUALITY SYSTEM
3.1.1 Regulatory Inspection for GLP Quality System
3.1.2 Good Laboratory Practice Inspections
3.1.3 GLP Quality System Objectives
3.2 GLOBAL GLP REGULATIONS AND PRINCIPLES
3.2.1 General
3.2.2 Responsibilities and Compliance
3.2.3 Statement of Compliance in the Final Report
3.2.4 Protocol Approval
3.2.5 Assignment of Study Director
3.2.6 Laboratory Qualification/Certification
3.2.7 Authority Inspections
3.2.8 Archiving Requirements
3.3 IMPLEMENTATION OF GLP REGULATIONS AND OECD PRINCIPLES
3.3.1 Planning (Master Schedule)
3.3.2 Personnel Organization
3.3.3 Curriculum Vitae
3.3.4 Rules of the Conducts of Studies
3.3.5 Content of Study Protocol
3.3.6 Approval of Study Protocol
3.3.7 Distribution of Study Protocol
3.3.8 Protocol Amendment
3.3.9 Standard Operating Procedures
3.3.10 SOP System Overview
3.3.11 Characterization
3.3.12 Test Item/Article Control before Formulation
3.3.13 Preparation of the Dose Formulation
3.3.14 Sampling and Quality Control of Dose Formulation
3.4 INITIATIVES AND IMPLEMENTATION OF BIOANALYTICAL METHODVALIDATION (GUIDANCEFORINDUSTRYBMV-MAY2001)
3.4.1 Summary
REFERENCES
4 FUNDAMENTAL ELEMENTS AND STRUCTURES FOR REGULATED BIOANALYTICAL LABORATORIES
4.1 INTRODUCTION
4.2 FUNDAMENTAL ELEMENTS FOR BIOANALYTICAL LABORATORIES
4.2.1 Document Retention and Archiving
4.3 BASIC REQUIREMENTS FOR GLP INFRASTRUCTURE AND OPERATIONS
4.4 GxP QUALITY SYSTEMS
4.4.1 Laboratory Instrument Qualification and Validation
4.4.2 Procedural Elements and Function that Maintain Bioanalytical Data Integrity for GLP Studies
REFERENCES
5 TECHNICAL AND REGULATORY ASPECTS OF BIOANALYTICAL LABORATORIES
5.1 FUNDAMENTAL ROLES AND RESPONSIBILITIES OF BIOANALYTICAL LABORATORIES
5.1.1 Technical Functions of Bioanalytical Laboratories
5.1.2 Basic Processes in Bioanalytical Method Development, Validation, and Sample Analysis
5.2 QUALIFICATION OF PERSONNEL, INSTRUMENTATION, AND ANALYTICAL PROCEDURES
5.2.1 From Regulatory Perspectives: Personnel, Training, and Qualification
5.2.2 Facility Design and Qualifications
5.2.3 Equipment Design and Qualification
5.2.4 Analytical/Bioanalytical Method Qualification and Validation along with Related SOPs
5.3 REGULATORY COMPLIANCE WITH GLP WITHIN BIOANALYTICAL LABORATORIES
5.4 JOINT-EFFORT FROM INDUSTRIES AND REGULATORY AGENCIES
5.4.1 Ligand-Binding Assays In-Study Acceptance Criteria
5.4.2 Determination of Metabolites during Drug Development
5.4.3 Incurred Sample Analysis
5.4.4 Documentation Issues
5.4.5 Analytical/Validation Reports
5.4.6 Source Data Documentation
5.4.7 Final Report Documentation
5.4.8 Stability Recommendation
5.4.9 Matrix Effects for Mass Spectrometric-Based Assays
5.4.10 System Suitability
5.4.11 Reference Standards
5.4.12 Validation Topics with No Consensus
5.4.13 Specific Criteria for Cross-Validation
5.4.14 Separate Stability Experiments Required at 70º C if Stability Shown at 20º C
5.4.15 Stability Criteria for Stock Solution Stability
5.4.16 Acceptance Criteria for Internal Standards
5.4.17 Summary
REFERENCES
6 COMPETITIVENESS OF BIOANALYTICAL LABORATORIES-TECHNICAL AND REGULATORY PERSPECTIVES
6.1 TECHNICAL ASPECT OF COMPETITIVE BIOANALYTICAL LABORATORIES
6.2 BIOANALYTICAL PROCESSES AND TECHNIQUES
6.2.1 Sample Generation, Shipment, and Storage
6.2.2 Sample Preparation
6.3 ENHANCING THROUGHPUT AND EFFICIENCY IN BIOANALYSIS
6.3.1 Chromatographic Separation
6.3.2 Selective and Sensitive Detection
6.4 TECHNICAL CHALLENGES AND ISSUES ON REGULATED BIOANALYSIS
6.4.1 Matrix Effect
6.4.2 Method Validation and Critical Issues during Sample Analysis
6.4.3 Method Transfer
6.5 REGULATORY ASPECTS OF COMPETITIVE BIOANALYTICAL LABORATORIES
6.5.1 General Consideration
6.5.2 Historical Perspective
6.5.3 Personnel-Training and Qualification
6.5.4 Facility-Design and Qualifications
6.5.5 Equipment Design and Qualification
6.5.6 Standard Operating Procedures
6.5.7 Laboratory/Facility Qualification Perspectives
6.6 ADVANCED/COMPETITIVE BIOANALYTICAL LABORATORIES
6.6.1 Strategy Versus Tactics
6.6.2 Bioanalytical Laboratory Assessment
6.6.3 Capacity
6.6.4 Experience
6.6.5 Quality
6.6.6 Performance and Productivity Measures
6.6.7 Information Technology and Data Management
6.6.8 Communication
6.6.9 Financial Stability
6.6.10 Ease of Use
6.6.11 Contracting Bioanalytical Services
6.6.12 The Contracting Process
6.7 APPLICATIONS AND ADVANCES IN BIOMARKER AND/OR LIGAND-BINDING ASSAYS WITHIN BIOANALYTICAL LABORATORIES
REFERENCES
7 SPONSOR AND FDA/REGULATORY AGENCY GLP INSPECTIONS AND STUDY AUDITS
7.1 GLP VERSUS BIOMEDICAL RESEARCH MONITORING AND MUTUAL ACCEPTANCE OF DATA FOR GLOBAL REGULATIONS AND INSPECTIONS
7.2 PURPOSES AND BENEFITS OF REGULATORY INSPECTIONS/AUDITS
7.2.1 Criteria for Selecting Ongoing and Completed Studies
7.2.2 Areas of Expertise of the Facility
7.2.3 Establishment Inspections
7.2.4 Organization and Personnel (21 CFR 58.29, 58.31, 58.33)
7.2.5 Quality Assurance Unit (QAU
21 CFR 58.35)
7.2.6 Facilities (21 CFR 58.41-58.51)
7.2.7 Equipment (21 CFR 58.61-58.63)
7.2.8 Testing Facility Operations (21 CFR 58.81)
7.2.9 Reagents and Solutions (21 CFR 58.83)
7.2.10 Animal Care (21 CFR 58.90)
7.2.11 Test and Control Articles (21 CFR 58.105-58.113)
7.2.12 Test and Control Article Handling (21 CFR 58.107)
7.2.13 Protocol and Conduct of Nonclinical Laboratory Study (21 CFR 58.120-58.130)
7.2.14 Study Protocol (21 CFR 58.120)
7.2.15 Test System Monitoring
7.2.16 Records and Reports (21 CFR 58.185-58.195)
7.2.17 Data Audit
7.2.18 General
7.2.19 Final Report Versus Raw Data
7.2.20 Specimens Versus Final Report
7.2.21 Refusal to Permit Inspection
7.2.22 Sealing of Research Records
7.2.23 Samples
7.3 TYPICAL INSPECTIONS/AUDITS AND THEIR OBSERVATIONS
7.4 REGULATORY CHALLENGES FOR BIOANALYTICAL LABORATORIES
7.4.1 Introduction
7.4.2 Analysis of Current FDA Inspection Trends
7.4.3 Discussion and Analysis of Specific Potential FDA 483 Observation Issues
7.4.4 Method Validation Issues
7.4.5 Batch Runs Acceptance Criteria Issues
7.4.6 Events/Deviations Investigation/Resolution Issues
7.4.7 Test Specimen Accountability Issue
7.4.8 Recommendations to Support an Effective FDA Inspection Readiness Preparation
7.5 HANDLING AND FACILITATING GLP OR GXP AUDITS/ INSPECTIONS
7.5.1 General Preparation for an Inspection
7.5.2 Why Are Audits/Inspections Needed and Conducted?
7.5.3 Written Policy in Place
7.5.4 Positions on Controversial Issues
7.5.5 The Inspection Coordinator
7.5.6 Follow-Up Procedures
7.5.7 Summary
REFERENCES
8 CURRENT STRATEGIES AND FUTURE TRENDS
8.1 STRATEGIES FROM GENERAL LABORATORY AND REGULATORY PERSPECTIVES
8.2 STRATEGIES FROM TECHNICAL AND OPERATIONAL PERSPECTIVES
8.3 BIOLOGICAL SAMPLE COLLECTION, STORAGE, AND PREPARATION
8.3.1 Sample Collection and Storage
8.3.2 Sample Preparation Techniques
8.3.3 Off-Line Sample Extraction
8.3.4 On-Line Sample Extraction
8.4 STRATEGIES FOR ENHANCING MASS SPECTROMETRIC DETECTION
8.4.1 Enhanced Mass Resolution
8.4.2 Atmospheric Pressure Photoionization
8.4.3 High-Field Asymmetric Waveform Ion Mobility Spectrometry
8.4.4 Electron Capture Atmospheric Pressure Chemical Ionization
8.4.5 Mobile Phase Optimization for Improved Detection and Quantitation
8.4.6 Anionic and Cationic Adducts as Analytical Precursor Ions
8.4.7 Derivatization
8.5 STRATEGIES FOR ENHANCING CHROMATOGRAPHY
8.5.1 Ultra-Performance Chromatography
8.5.2 Hydrophilic Interaction Chromatography for Polar Analytes
8.5.3 Specialized Reversed-Phase Columns for Polar Analytes
8.5.4 Ion-Pair Reversed-Phase Chromatography for Polar Analytes
8.6 POTENTIAL PITFALLS IN LC-MS/MS BIOANALYSIS
8.6.1 Interference from Metabolites or Prodrugs due to In-Source Conversion to Drug
8.6.2 Interference from Metabolites or Prodrugs due to Simultaneous M + H+ and M + NH4+ Formation or Arising from Isotopic Distribution
8.6.3 Pitfall in Analysis of Two Interconverting Analytes due to Inappropriate Method Design
8.6.4 Matrix Effect
8.7 TRENDS IN HIGH-THROUGHPUT QUANTITATION
8.7.1 System Throughput
8.7.2 High-Speed HPLC
8.8 TRENDS IN HYBRID COUPLING DETECTION TECHNIQUES
8.9 TRENDS IN INTERNAL R&D AND EXTERNAL OUTSOURCING
8.10 TRENDS IN LIGAND-BINDING ASSAYS AND LC-MS/MS FOR BIOMARKER ASSAY APPLICATIONS
8.11 TRENDS IN STUDY DESIGN AND EVALUATION RELATING TO BIOANALYSIS
8.12 TRENDS IN APPLYING GLP TO IN VITRO STUDIES IN SUPPORT OF REGULATORY SUBMISSIONS
8.13 TRENDS IN GLOBAL R&D OPERATIONS
8.14 TRENDS IN REGULATORY IMPLEMENTATIONS
8.14.1 Calibration Range and Quality Control Samples
8.14.2 Incurred Sample Reproducibility (Duplicate Sample Analysis)
8.14.3 LIMS and Electronic Data Handling, Security, Archiving, and Submission
8.15 TRENDS IN GLOBAL REGULATIONS AND QUALITY STANDARDS
8.16 TRENDS IN COMPLIANCE WITH 21 CFR PART 11
8.16.1 21CFR Part 11 Software Requirements
8.16.2 Building a Roadmap for Compliance with 21 CFR Part 11
8.16.3 Low Hanging Fruits in the Roadmap for Compliance with 21 CFR Part 11
8.17 SUMMARY
REFERENCES
9 GENERAL TERMINOLOGIES OF GxP AND BIOANALYTICAL LABORATORIES
9.1 GENERAL TERMINOLOGIES FOR GxP AND BIOANALYTICAL LABORATORIES
9.2 GLP BASIC CONCEPTS AND IMPLEMENTATION
9.2.1 The Study Protocol
9.2.2 Raw Data
9.2.3 The GLP Archive and the Archivist
9.2.4 Expansion of GLP Scope
9.2.5 OECD GLP
9.3 GLP GUIDANCE DOCUMENTS
9.3.1 FDA Guidance for Industry on Bioanalytical Method Validation
9.3.2 OECD GLP Guidance Documents
9.3.3 Swiss GLP Guidance Documents
REFERENCES AND SOURCES FOR ABOVE TERMINOLOGIES
Appendix A: GENERIC CHECKLIST FOR GLP/GXP INSPECTIONS/AUDITS
Appendix B: GENERAL TEMPLATE FOR SOP
Appendix C: TYPICAL SOPs FOR GLP/REGULATED BIOANALYTICAL LABORATORY
QUALITY ASSURANCE-GLP
BIOANALYTICAL-GLP LABORATORIES
Appendix D: BASIC EQUIPMENT/APPARATUS FOR BIOANALYTICAL LABORATORY
Appendix E: WEBSITE LINKAGES FOR REGULATED BIOANALYSIS
INDEX

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