Regulated Bioanalytical Laboratories Technical and Regulatory Aspects from Global Perspectives

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

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.

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