| D&MD's Guide to Good Laboratory Practice, 3rd Edition examines the GLP regulations in the United States and other countries in detail, and gives firm guidelines for compliance, using as a basis the GLP requirements published in the U.S.A Code of Federal Regulations, Title 21, Part 58, 2006 Edition (21CFR58). The guidelines laid down by other countries, especially members of the European Community, are based upon guidelines developed by the Organization for Economic Development (OECD) in 1980. Guidelines on safety testing and analytical methods issued by the International Conference on Harmonization (ICH) are also reviewed. Special attention is paid to the documentation and the preparations for internal and external inspections and audits.
|
- 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
- TABLE OF EXHIBITS
- 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
Share this report
Other tasks Related Markets Drug Discovery Reports Free Alert Me service Receive bi-weekly email alerts on new market research Sign Up Today!
|
