Good Laboratory Practices (GLP) Training

– The History & Purpose of GLP

What is GLP?

Test Facility Organisation & Personnel

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, Materials & Reagents
General requirements

Computerised system validation

Test Systems

Physical/chemical test systems

 

Test & Reference Items

Reserve samples

Standard Operating Procedures

Expected coverage

Performance of the Study

Content of the study plan

Amendments

Deviations

Reporting of Study Results

Content of the final report

Storage & Retention of Records & Materials

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

Sponsors

Multi-site studies

In-vitro studies

GLP Programmes

 

 

 

 

Information Notice:
The information on this page is intended for scientific, educational, and general informational purposes. Clinical approaches, availability, and regulatory status may vary by country, institution, and medical indication. For individual medical decisions, readers should consult qualified healthcare professionals and accredited medical centers.
Editorial Note:
This article has been prepared by the NBScience editorial team within the scope of clinical research, biotechnology, and international medical information.

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