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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.

Europe

 

EU Directive

99/12/EC

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 EEA relevance

Quite detailed, can be used by inspectors as checklist

 

Links to Swiss (GLP/OECD) Working Group on Information Technology (AGIT)

US FDA

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 Monitoring

 

Positioning Paper of the Working Group on Good Laboratory Practice:

'Outsourcing' of Inspection Functions by GLP Compliance Monitoring