良好实验室规范 (良好实验室规范) Training
– The History & Purpose of GLP
What is GLP?
Test Facility Organisation & 人员
Management responsibilities
Study Director responsibilities
Principal Investigator responsibilities
Study Personnel responsibilities
Study plans, SOPs and the master schedule
Inspections
Final reports
Reporting QA findings
The QA statement
Test facility & test site QA differences
Facilities
Test system facilities
Facilities for handling test & reference items
Archive facilities
Waste disposal
Apparatus, 材料 & Reagents
General requirements
Computerised system validation
Test Systems
Physical/chemical test systems
Test & Reference Items
Reserve samples
标准作业程序
Expected coverage
研究的表现
Content of the study plan
Amendments
Deviations
研究结果报告
Content of the final report
贮存 & 记录的保留 & 材料
Retention periods
Submission to the archive
Retention
Disposal & transfer
Additional OECD GLP Consensus/Advisory Documents & Position Papers
Suppliers
Field studies
Short-term studies
Computer systems
赞助商
Multi-site studies
In-vitro studies
GLP Programmes
