Michael Zhou
Regulated Bioanalytical Laboratories
Technical and Regulatory Aspects from Global Perspectives
Michael Zhou
Regulated Bioanalytical Laboratories
Technical and Regulatory Aspects from Global Perspectives
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This book provides useful information for bioanalytical / analytical scientists, analysts, quality assurance managers, and all personnel in bioanalytical laboratories through all aspects of bioanalytical technical and regulatory perspectives within bioanalytical operations and processes. Readers learn how to develop and implement strategies for routine, non-routine, and standard bioanalytical methods and on the entire equipment hardware and software qualification process. The book also gives guidelines on qualification of certified standards and in-house reference material as well as on people…mehr
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This book provides useful information for bioanalytical / analytical scientists, analysts, quality assurance managers, and all personnel in bioanalytical laboratories through all aspects of bioanalytical technical and regulatory perspectives within bioanalytical operations and processes. Readers learn how to develop and implement strategies for routine, non-routine, and standard bioanalytical methods and on the entire equipment hardware and software qualification process. The book also gives guidelines on qualification of certified standards and in-house reference material as well as on people qualification. Finally, it guides readers through stressless internal and third party laboratory audits and inspections. It takes account to most national and international regulations and quality and accreditation standards, along with corresponding interpretation and inspection guides. The author elaborates on highly comprehensive content, making it easy not only to learn the subject but also to quickly implement the recommendations.
Produktdetails
- Produktdetails
- Verlag: Wiley & Sons
- 1. Auflage
- Seitenzahl: 560
- Erscheinungstermin: 22. Februar 2011
- Englisch
- Abmessung: 244mm x 159mm x 38mm
- Gewicht: 964g
- ISBN-13: 9780470476598
- ISBN-10: 0470476591
- Artikelnr.: 30976583
- Verlag: Wiley & Sons
- 1. Auflage
- Seitenzahl: 560
- Erscheinungstermin: 22. Februar 2011
- Englisch
- Abmessung: 244mm x 159mm x 38mm
- Gewicht: 964g
- ISBN-13: 9780470476598
- ISBN-10: 0470476591
- Artikelnr.: 30976583
Michael Zhou, PhD, is Director of Bioanalytical Chemistry at Synta Pharmaceuticals Corporation and a highly regarded expert on analytical/bioanalytical operations, regulatory compliance, including Good Laboratory Practice (GLP), cGMP, GCP regulations, and ICH, GCLP, BMV guidelines. Dr. Zhou has given numerous presentations and workshops / short courses on the topics at national and international conferences and has authored over fifty research articles and two book chapters on analytical/bioanalytical chemistry
Preface. Acknowledgment. Contributors and Advisors. 1 Introduction,
Objectives, and Key Requirements for GLP Regulations. 1.1 Introduction. 1.2
Objectives and Key Requirements for GLP Regulations. 1.3 Fundamental
Understanding of GLP Regulations and Principles. 1.4 Key Elements of
Bioanalytical Methods Validation. 1.5 Basic Principles of Bioanalytical
Method Validation and Establishment. References. 2 Historic Perspectives of
GLP Regulations, Applicability, and Relation to Other Regulations. 2.1
Historic Perspectives of GLP Regulations. 2.2 Applicability and Relations
to Other Regulations/Principles. 2.3 Comparison of FDA GLP, EPA GLP
Regulations, and OECD GLP Principles. 2.4 Applications of GLP to Multiple
Site Studies. 2.5 21 CFR Part 11 in Relation to GLP Programs. 2.6 GLP,
cGMP, and ISO Applicabilities, Similarity, and Differences. 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. 3.2 Global GLP Regulations and Principles. 3.3
Implementation of GLP Regulations and OECD Principles. 3.4 Initiatives and
Implementation of Bioanalytical Method Validation (Guidance for Industry
BMV--May 2001). References. 4 Fundamental Elements and Structures for
Regulated Bioanalytical Laboratories. 4.1 Introduction. 4.2 Fundamental
Elements for Bioanalytical Laboratories. 4.3 Basic Requirements for GLP
Infrastructure and Operations. 4.4 GxP Quality Systems References. 5
Technical and Regulatory Aspects of Bioanalytical Laboratories. 5.1
Fundamental Roles and Responsibilities of Bioanalytical Laboratories. 5.2
Qualification of Personnel, Instrumentation, and Analytical Procedures. 5.3
Regulatory Compliance with GLP Within Bioanalytical Laboratories. 5.4
Joint-Effort from Industries and Regulatory Agencies. References. 6
Competitiveness of Bioanalytical Laboratories--Technical and Regulatory
Perspectives. 6.1 Technical Aspect of Competitive Bioanalytical
Laboratories. 6.2 Bioanalytical Processes and Techniques. 6.3 Enhancing
Throughput and Efficiency in Bioanalysis. 6.4 Technical Challenges and
Issues on Regulated Bioanalysis. 6.5 Regulatory Aspects of Competitive
Bioanalytical Laboratories. 6.6 Advanced/Competitive Bioanalytical
Laboratories. 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. 7.3 Typical Inspections/Audits and Their Observations.
7.4 Regulatory Challenges for Bioanalytical Laboratories. 7.5 Handling and
Facilitating GLP or GxP Audits/Inspections. 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.
8.4 Strategies for Enhancing Mass Spectrometric Detection. 8.5 Strategies
for Enhancing Chromatography. 8.6 Potential Pitfalls in LC-MS/MS
Bioanalysis. 8.7 Trends in High-Throughput Quantitation. 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. 8.15 Trends in Global
Regulations and Quality Standards. 8.16 Trends in 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. 9.3
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. Appendix D Basic Equipment/Apparatus for
Bioanalytical Laboratory. Appendix E Website Linkages for Regulated
Bioanalysis. Index.
Objectives, and Key Requirements for GLP Regulations. 1.1 Introduction. 1.2
Objectives and Key Requirements for GLP Regulations. 1.3 Fundamental
Understanding of GLP Regulations and Principles. 1.4 Key Elements of
Bioanalytical Methods Validation. 1.5 Basic Principles of Bioanalytical
Method Validation and Establishment. References. 2 Historic Perspectives of
GLP Regulations, Applicability, and Relation to Other Regulations. 2.1
Historic Perspectives of GLP Regulations. 2.2 Applicability and Relations
to Other Regulations/Principles. 2.3 Comparison of FDA GLP, EPA GLP
Regulations, and OECD GLP Principles. 2.4 Applications of GLP to Multiple
Site Studies. 2.5 21 CFR Part 11 in Relation to GLP Programs. 2.6 GLP,
cGMP, and ISO Applicabilities, Similarity, and Differences. 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. 3.2 Global GLP Regulations and Principles. 3.3
Implementation of GLP Regulations and OECD Principles. 3.4 Initiatives and
Implementation of Bioanalytical Method Validation (Guidance for Industry
BMV--May 2001). References. 4 Fundamental Elements and Structures for
Regulated Bioanalytical Laboratories. 4.1 Introduction. 4.2 Fundamental
Elements for Bioanalytical Laboratories. 4.3 Basic Requirements for GLP
Infrastructure and Operations. 4.4 GxP Quality Systems References. 5
Technical and Regulatory Aspects of Bioanalytical Laboratories. 5.1
Fundamental Roles and Responsibilities of Bioanalytical Laboratories. 5.2
Qualification of Personnel, Instrumentation, and Analytical Procedures. 5.3
Regulatory Compliance with GLP Within Bioanalytical Laboratories. 5.4
Joint-Effort from Industries and Regulatory Agencies. References. 6
Competitiveness of Bioanalytical Laboratories--Technical and Regulatory
Perspectives. 6.1 Technical Aspect of Competitive Bioanalytical
Laboratories. 6.2 Bioanalytical Processes and Techniques. 6.3 Enhancing
Throughput and Efficiency in Bioanalysis. 6.4 Technical Challenges and
Issues on Regulated Bioanalysis. 6.5 Regulatory Aspects of Competitive
Bioanalytical Laboratories. 6.6 Advanced/Competitive Bioanalytical
Laboratories. 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. 7.3 Typical Inspections/Audits and Their Observations.
7.4 Regulatory Challenges for Bioanalytical Laboratories. 7.5 Handling and
Facilitating GLP or GxP Audits/Inspections. 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.
8.4 Strategies for Enhancing Mass Spectrometric Detection. 8.5 Strategies
for Enhancing Chromatography. 8.6 Potential Pitfalls in LC-MS/MS
Bioanalysis. 8.7 Trends in High-Throughput Quantitation. 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. 8.15 Trends in Global
Regulations and Quality Standards. 8.16 Trends in 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. 9.3
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. Appendix D Basic Equipment/Apparatus for
Bioanalytical Laboratory. Appendix E Website Linkages for Regulated
Bioanalysis. Index.
Preface. Acknowledgment. Contributors and Advisors. 1 Introduction,
Objectives, and Key Requirements for GLP Regulations. 1.1 Introduction. 1.2
Objectives and Key Requirements for GLP Regulations. 1.3 Fundamental
Understanding of GLP Regulations and Principles. 1.4 Key Elements of
Bioanalytical Methods Validation. 1.5 Basic Principles of Bioanalytical
Method Validation and Establishment. References. 2 Historic Perspectives of
GLP Regulations, Applicability, and Relation to Other Regulations. 2.1
Historic Perspectives of GLP Regulations. 2.2 Applicability and Relations
to Other Regulations/Principles. 2.3 Comparison of FDA GLP, EPA GLP
Regulations, and OECD GLP Principles. 2.4 Applications of GLP to Multiple
Site Studies. 2.5 21 CFR Part 11 in Relation to GLP Programs. 2.6 GLP,
cGMP, and ISO Applicabilities, Similarity, and Differences. 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. 3.2 Global GLP Regulations and Principles. 3.3
Implementation of GLP Regulations and OECD Principles. 3.4 Initiatives and
Implementation of Bioanalytical Method Validation (Guidance for Industry
BMV--May 2001). References. 4 Fundamental Elements and Structures for
Regulated Bioanalytical Laboratories. 4.1 Introduction. 4.2 Fundamental
Elements for Bioanalytical Laboratories. 4.3 Basic Requirements for GLP
Infrastructure and Operations. 4.4 GxP Quality Systems References. 5
Technical and Regulatory Aspects of Bioanalytical Laboratories. 5.1
Fundamental Roles and Responsibilities of Bioanalytical Laboratories. 5.2
Qualification of Personnel, Instrumentation, and Analytical Procedures. 5.3
Regulatory Compliance with GLP Within Bioanalytical Laboratories. 5.4
Joint-Effort from Industries and Regulatory Agencies. References. 6
Competitiveness of Bioanalytical Laboratories--Technical and Regulatory
Perspectives. 6.1 Technical Aspect of Competitive Bioanalytical
Laboratories. 6.2 Bioanalytical Processes and Techniques. 6.3 Enhancing
Throughput and Efficiency in Bioanalysis. 6.4 Technical Challenges and
Issues on Regulated Bioanalysis. 6.5 Regulatory Aspects of Competitive
Bioanalytical Laboratories. 6.6 Advanced/Competitive Bioanalytical
Laboratories. 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. 7.3 Typical Inspections/Audits and Their Observations.
7.4 Regulatory Challenges for Bioanalytical Laboratories. 7.5 Handling and
Facilitating GLP or GxP Audits/Inspections. 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.
8.4 Strategies for Enhancing Mass Spectrometric Detection. 8.5 Strategies
for Enhancing Chromatography. 8.6 Potential Pitfalls in LC-MS/MS
Bioanalysis. 8.7 Trends in High-Throughput Quantitation. 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. 8.15 Trends in Global
Regulations and Quality Standards. 8.16 Trends in 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. 9.3
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. Appendix D Basic Equipment/Apparatus for
Bioanalytical Laboratory. Appendix E Website Linkages for Regulated
Bioanalysis. Index.
Objectives, and Key Requirements for GLP Regulations. 1.1 Introduction. 1.2
Objectives and Key Requirements for GLP Regulations. 1.3 Fundamental
Understanding of GLP Regulations and Principles. 1.4 Key Elements of
Bioanalytical Methods Validation. 1.5 Basic Principles of Bioanalytical
Method Validation and Establishment. References. 2 Historic Perspectives of
GLP Regulations, Applicability, and Relation to Other Regulations. 2.1
Historic Perspectives of GLP Regulations. 2.2 Applicability and Relations
to Other Regulations/Principles. 2.3 Comparison of FDA GLP, EPA GLP
Regulations, and OECD GLP Principles. 2.4 Applications of GLP to Multiple
Site Studies. 2.5 21 CFR Part 11 in Relation to GLP Programs. 2.6 GLP,
cGMP, and ISO Applicabilities, Similarity, and Differences. 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. 3.2 Global GLP Regulations and Principles. 3.3
Implementation of GLP Regulations and OECD Principles. 3.4 Initiatives and
Implementation of Bioanalytical Method Validation (Guidance for Industry
BMV--May 2001). References. 4 Fundamental Elements and Structures for
Regulated Bioanalytical Laboratories. 4.1 Introduction. 4.2 Fundamental
Elements for Bioanalytical Laboratories. 4.3 Basic Requirements for GLP
Infrastructure and Operations. 4.4 GxP Quality Systems References. 5
Technical and Regulatory Aspects of Bioanalytical Laboratories. 5.1
Fundamental Roles and Responsibilities of Bioanalytical Laboratories. 5.2
Qualification of Personnel, Instrumentation, and Analytical Procedures. 5.3
Regulatory Compliance with GLP Within Bioanalytical Laboratories. 5.4
Joint-Effort from Industries and Regulatory Agencies. References. 6
Competitiveness of Bioanalytical Laboratories--Technical and Regulatory
Perspectives. 6.1 Technical Aspect of Competitive Bioanalytical
Laboratories. 6.2 Bioanalytical Processes and Techniques. 6.3 Enhancing
Throughput and Efficiency in Bioanalysis. 6.4 Technical Challenges and
Issues on Regulated Bioanalysis. 6.5 Regulatory Aspects of Competitive
Bioanalytical Laboratories. 6.6 Advanced/Competitive Bioanalytical
Laboratories. 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. 7.3 Typical Inspections/Audits and Their Observations.
7.4 Regulatory Challenges for Bioanalytical Laboratories. 7.5 Handling and
Facilitating GLP or GxP Audits/Inspections. 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.
8.4 Strategies for Enhancing Mass Spectrometric Detection. 8.5 Strategies
for Enhancing Chromatography. 8.6 Potential Pitfalls in LC-MS/MS
Bioanalysis. 8.7 Trends in High-Throughput Quantitation. 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. 8.15 Trends in Global
Regulations and Quality Standards. 8.16 Trends in 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. 9.3
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. Appendix D Basic Equipment/Apparatus for
Bioanalytical Laboratory. Appendix E Website Linkages for Regulated
Bioanalysis. Index.