This book provides much–needed practical information on how to generate and review data for regulatory consideration in the biotech, pharmaceutical, and life science industries. It explains in detail how to develop and implement effective strategies for meeting technical challenges, Good Laboratory Practice (GLP) and GxP requirements from global perspectives, with an emphasis on tools and techniques for ensuring the quality and integrity of study data.
Readers will gain invaluable insight into the entire hardware and software qualification process as well as people qualification, learn how to get through laboratory audits and inspections with ease, and acquire a thorough understanding of all regulatory issues relevant to their work. Coverage includes:
International standards and regulations from the US FDA, USP, ICH, OECD, WHO, ISO, EMEA, and EU
Requirements, objectives, and implementation of GLP and GxP quality systems
Facility and personnel infrastructure and qualification
Techniques for modern bioanalytical / analytical sample preparation and essential concepts in extraction chemistry and separation mechanisms
Specific strategies for the efficient use of laboratory automation with high throughput
Instrumental analysis for hyphenated techniques such as LC–MS/MS and so on
Important laboratory applications of Ligand Binding Assays (LBAs) andbiomarker assays
A must–have for scientists, graduate students, and quality assurance managers in bioanalytical laboratories, Regulated Bioanalytical Laboratories is also an essential reference for anyone interested in the overall technical know–how, regulatory, and quality assurance trends in the field.
Contributors and Advisors.
1 Introduction, Objectives, and Key Requirements for GLP Regulations.
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.
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.
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).
4 Fundamental Elements and Structures for Regulated Bioanalytical Laboratories.
4.2 Fundamental Elements for Bioanalytical Laboratories.
4.3 Basic Requirements for GLP Infrastructure and Operations.
4.4 GxP Quality Systems
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.
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.
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.
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.
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.