Jürg P. Seiler

Good Laboratory Practice

• Buch

Produktdetails

• Verlag: Springer Berlin
• ISBN-13: 9783540679387
• ISBN-10: 3540679383
• Artikelnr.: 26710116

Inhaltsangabe

I. What is Good Laboratory Practice All About?
1. Introduction
2. The History of GLP
3. The Idea Behind GLP
4. The Areas of Application
5. The Pillars of Good Laboratory Practice
6. Where Can GLP be Profitably Applied?
7. GLP and Other Laboratory Quality Systems

II. How is Good Laboratory Practice Regulated?
1. Introduction
2. Definitions in GLP
3. Reponsibilities in Good Laboratory Practice
4. The Quality Assurance Programme
5. Facilities
6. Apparatus, Materials and Reagents
7. Computerised Systems
8. Test Systems
9. Test and References Items
10. Standard Operating Procedures
11. Study Performance and Reporting
12. The Archives

III. How can Good Laboratory Practice be Introduced in a Test Facility?
1. Introduction
2. General Aspects
3. A General Way to Implementation IV. How is Compliance with Good Laboratory Practice Monitored?
1. Introduction
2. National Monitoring Authorities
3. MOUs, MRAs, and MJVs.