GLP Regulations/Guidelines - International Countries
Pharmaceutical Industry is challenged with many national and
international regulations and guidelines. On this site you can find most
important documents related to Good Laboratory Practices.
Commission Directive 1999/12/EC of 8 March 1999 adapting to technical
progress for the second time the Annex to Council Directive 88/320/EEC on
the inspection and verification of good laboratory practice (GLP) (Text with
Quite detailed, can be used by inspectors as checklist
Links to Swiss (GLP/OECD) Working Group on Information
Link to US FDA - United States Food and Drug Administration
OECD - Organization for Economic Cooperation and Development
Good Laboratory Practice OECD GLP Principles and Consensus Papers
Downloaded from the OECD Website.
Go to the start site and select Good Laboratory Practice and Compliance
Positioning Paper of the Working Group on Good
Inspection Functions by GLP Compliance Monitoring