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Requesting and Carrying out Inspections and Study Audits in another country - PharmaFacts
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Requesting and Carrying out Inspections and Study Audits in another country

Guidances - OECD Guidances

Environmental health and safety studies for the  assessment of chemicals and chemical products are increasingly being carried out in multiple sites. This holds not only for field studies, but also for various phases of toxicology studies. The Revised Principles of Good  Laboratory Practice∗, adopted by OECD in 1997, cover the various aspects of the organisation of such studies. Nevertheless, the Working Group on Good Laboratory Practice felt that further guidance was needed about requesting and carrying out inspections and study audits of multi-site studies when the study site(s) are located in another country than that of the main test facility, as accorded by the 1989 Council Decision-Recommendation on Compliance with Principles of GLP [C(89)87(Final), Part II, 2.iii].

Requesting_and_Carrying_out_Inspections_and_Study_Audits_in_another_country.pdf