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OECD Guidances - PharmaFacts
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OECD Guidances

OECD Resources

The Organisation for Economic Co-operation and Development (OECD) is an intergovernmental organisation in which representatives of 29 industrialised countries in North America, Europe and the Pacific, as well as the European Commission, meet to co-ordinate and harmonize policies, discuss issues of mutual concern, and work together to respond to international problems. Most of the OECD’s work is carried out by more than 200 specialised Committees and subsidiary groups composed of Member country delegates. Observers from several countries with special status at the OECD, and from interested international organisations, attend many of the OECD’s Workshops and other meetings. Committees and subsidiary groups are served by the OECD Secretariat, located in Paris, France, which is organised into Directorates and Divisions.

The work of the OECD related to chemical safety is carried out in the Environmental Health and Safety Division. The Environmental Health and Safety Division publishes free-of charge documents in six different series: Testing and Assessment; Principles on Good Laboratory Practice and Compliance Monitoring; Pesticides; Risk Management; Chemical Accidents and Harmonization of Regulatory Oversight in Biotechnology. More information about the Environmental Health and Safety Programme and EHS publications is available on OECD’s Web Site.

All introductory information is excerpted from the document in which it refers.  Introductory information is provided as a precursor for the docuement for identification purposes and is not meant to supplant or replace the need for the document in any way, shape, or form. -PharmaFacts

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The Role and Responsibility of the Sponsor in the Application of the Principles of GLP

Although the revised Principles of Good Laboratory Practice only explicitly assign a few responsibilities to the sponsor of a study, the sponsor has other implicit responsibilities. These arise from the fact that the sponsor is often the party who initiates one or more studies and directly submits the
results thereof to regulatory authorities. The sponsor must therefore assume an active role in confirming that all non-clinical health and environmental safety studies were conducted in compliance with GLP. Sponsors cannot rely solely on the assurances of test facilities they may have contracted to arrange or perform such studies. The guidance given below attempts to outline both the explicit and implicit responsibilities of a sponsor necessary to fulfil his obligations.



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Requesting and Carrying out Inspections and Study Audits in another country

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].



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The Application of the OECD Principles of GLP to the Organisation and Management of Multi-site Studies

It is becoming increasingly common for non-clinical health and environmental safety studies to be conducted at more than one site. For example, companies may use facilities which specialise in different activities located at sites in various countries; or field trials on agrochemicals may have to be conducted on different crops or soil types located in different regions or countries. Toxicology studies may also have phases of the study conducted by different departments of the same organisation or different companies.

In the framework of the second OECD Consensus  Workshop on Good Laboratory Practice, held 21st – 23rd May 1991, in Vail, Colorado, experts discussed and reached consensus on the application of the GLP Principles to field studies. An OECD Consensus Document on “The Application of the GLP Principles to Field Studies” was subsequently published in 1992 and revised in 1999 [ENV/JM/MONO(99)23]. Among other aspects, this document introduced the concept of a “Principal Investigator” who could assume delegated responsibility for a phase of a field study being conducted at a test site that was remote from the Study Director. Although the concept of a Principal Investigator had originally been developed to assist in the conduct of field studies that included trials being conducted at several different locations, the concept is equally applicable to any other type of multi-site study.



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OECD Guidelines for the Testing of Chemicals