Guide to Good Laboratory Practice, 3rd Edition

Chapter 1: Executive Summary

Chapter 2: Introduction

• The Assurance of Quality in Drug Research, Development, and Pre-Clinical Testing
• Good Laboratory Practice and the Transfer of Technology
• The Cost of GLP Non-compliance

Chapter 3: International Regulations Governing GLP

• Chronology and Current Regulations
  • United States of America
  • Europe
  • Canada
  • Japan
• Comparison of the Regulations

Chapter 4: Critical Compliance Issues

• Organization and Personnel (Subpart B, 58.29- 35)
  • Matrix Organization
  • Personnel Qualifications, Training, and Behavior (see 58.29 & 58.31)
  • Management Responsibilities (See 58.31)
  • Specific Appointments: The Study Director (see 58.33)
  • The Quality Assurance Unit (see 58.35)
  • Facilities (Subpart C, 58.41 - 51)
    • Containment Issues
  • Animal Unit Design
  • Equipment (Subpart D, 58.61- 63) (OECD: “Apparatus“)
• Testing Facilities Operation (Subpart E 58.81 - 90)
  • Standard Operating Procedures ( 58.81)
  • Guide to SOP Writing
  • Reagents and Solutions ( 58.83)
  • Animal Care (58.90)
  • Test and Control Articles (Subpart F, 58.105- 113) (OECD: “Test & Reference Items“)
• Protocol for and Conduct of a Study (Subpart G, 58.120- 130)
  • The Study Protocol ( 58.120) (OECD “Study Plan“)
  • Conduct of the Study ( 58.130)
  • Recording of Data
  • Electronic Data Management
• Records and Reports (Subpart J, 58.185- 195)
  • The Final Report of the Study ( 58.185)
  • Archiving the Data ( 58.190)
  • Retention of Archived Records and Specimens ( 58.195)
  • Form of Retained Records ( 58.195 g)
  • Transfer of Records ( 58.195h)
• Conclusions

Chapter 5: Submitting Pre-clinical Study Findings in Clinical Trial Applications

• IND Contents According to FDA
• The ICH Common Technical Document
  • Nonclinical Summaries and Tables
  • Order of Presentation of Information within Sections
  • Module 4- Nonclinical Data

Chapter 6: GLP Inspections and Study Audits

• What Are Inspections and Audits?
  • Establishment Inspections
  • Key Inspection Points
  • Study Audits
  • Establishment Inspection Report (EIR)
  • Deviations which are not required to be notified by FDA 483 are:
• How to Survive Inspections and Audits
  • Before- Preparing for the Inspection
  • During- Inspection Days
  • After- Dealing with the Report
  • How Others Fared- Excerpts from Form 483

Chapter 7: Conclusions

Chapter 8: References and Further Reading

• Access to Regulatory Documents
• Useful Publications
  • Associations and Information Web Sites
  • GLP Consultants

Chapter 9: Appendices

• GLP Inspection Forms
• Texts of GLP Regulations
• Endnotes
• Japan Ordinance 21 & PAB 424, 1997

• Exhibit 2.1 What is Quality Assurance?
• Exhibit 2.2 The Stages in Drug Development
• Exhibit 3.1 Member Nations of OECD
• Exhibit 3.2 OECD Documents Concerning GLP and Compliance Monitoring
• Exhibit 3.3 Comparison of Contents of GLP Regulations
• Exhibit 3.4 Definitions of Major Terms
• Exhibit 4.1 Matrix Management Chart
• Exhibit 4.2 Sample Ground Rules for Laboratory Operation
• Exhibit 4.3 Section of a Study Schedule GANTT Chart (“On Target“ Software)
• Exhibit 4.4 Certificate of Analysis
• Exhibit 4.5 Suggested Layout for the Master SOP Manual
• Exhibit 4.6 Study Monitoring Record
• Exhibit 4.7 Critical Factors in Facility Compliance
• Exhibit 4.8 Biohazard Laminar-Flow Cabinet, Class II Type B1
• Exhibit 4.9 Animal Unit Layout
• Exhibit 4.10 Typical Equipment Maintenance Record
• Exhibit 4.11 Minimum List of SOPs Required (according to 21CFR58.81)
• Exhibit 4.12 Templates for SOP
• Exhibit 4.13 Solution Label
• Exhibit 4.14 Animal Cage Label
• Exhibit 4.15 Sample Container Label
• Exhibit 4.16 Sample Storage Box Label
• Exhibit 4.17 Label for Specimen Container
• Exhibit 4.18 Retention Times for Archived Materials
• Exhibit 4.19 Other Records to be Maintained
• Exhibit 5.1 Contents of the CTD
• Exhibit 5.2 TOC of Section 2.6
• Exhibit 5.3 Example of Pharmacology Summary Table
• Exhibit 5.4 Example of a Specific Pharmacokinetics Table
• Exhibit 5.5 Example of a Toxicology Summary Table
• Exhibit 5.6 Example of a Toxicokinetics Summary Graph
• Exhibit 5.7 Table of Contents of Module 4
• Exhibit 6.1 Inspection Request Form