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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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OECD Principles of Good Laboratory Practice

The purpose of these Principles of Good Laboratory Practice is to promote the development of quality test data. Comparable quality of test data forms the basis for the mutual acceptance of data among countries. If individual countries can confidently rely on test data developed in other  countries,duplicative testing can be avoided, thereby saving time and resources. The application of these Principles should help to avoid the creation of technical barriers to trade, and further improve the protection of
human health and the environment.

Principles on Good Laboratory Practice.pdf 


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OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring

The 1981 Council Decision on Mutual Acceptance of Data [C(81)30(Final)], of which the OECD Principles of Good Laboratory Practice1 are an integral part, includes an instruction for OECD to undertake activities "to facilitate internationally-harmonized approaches to assuring compliance" with the GLP Principles. Consequently, in order to promote the  implementation of comparable compliance monitoring procedures, and international acceptance, among Member countries the Council adopted in 1983 the Recommendation concerning the Mutual Recognition of Compliance with Good Laboratory Practice [C(83)95(Final)], which set out basic characteristics of the procedures for monitoring compliance. A Working Group on Mutual Recognition of Compliance with GLP was established in 1985, under the chairmanship of Professor V. Silano (Italy), to facilitate the practical implementation of the Council acts on GLP, develop common approaches to the technical and administrative problems related to GLP compliance and its monitoring, and develop arrangements for the mutual recognition of compliance monitoring procedures. The following countries and organisations participated in the Working Group: Australia, Belgium, Canada, Denmark, the Federal  Republic of Germany, Finland, France, Italy, Japan, Norway, the Netherlands, Portugal, Spain, Sweden, Switzerland, the United Kingdom, the United States, the Commission of the European Communities, the International Organization for Standardization, the Pharmaceuticals Inspections Convention, and the World Health Organization.


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Revised Guidance for the Conduct of Laboratory Inspections and Study Audit

The purpose of this document is to provide guidance for the conduct of Test Facility Inspections and Study Audits which would be mutually acceptable to OECD Member countries. It is principally concerned with Test Facility Inspections, an activity which occupies much of the time of GLP Inspectors. A Test Facility Inspection will usually include a Study Audit or "review" as a part of the inspection, but Study Audits will also have to be conducted from time to time at the request, for example, of a Regulatory Authority. General guidance for the conduct of Study Audits will be found at the end of this document.

Test Facility Inspections are conducted to determine the degree of conformity of test facilities and studies with GLP Principles and to determine the integrity of data to assure that resulting data are of adequate quality for assessment and decision-making by national Regulatory Authorities. They result in reports which describe the degree of adherence of a test facility to the GLP Principles. Test Facility Inspections should be conducted on a regular, routine basis to establish and maintain records of the GLP compliance status of test facilities.

Further clarification of many of the points in this document may be obtained by referring to the OECD Consensus Documents on GLP (on, e.g., the role and responsibilities of the Study Director).



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Quality Assurance and GLP

A quality assurance programme is defined in the Revised OECD Principles of Good Laboratory Practice as "a defined system, including personnel, which is independent of study conduct and is designed to assure test facility management of compliance with these Principles of Good Laboratory Practice" [Section I.2.2(8)]. The responsibilities of the management of a test facility include ensuring "that there is a Quality Assurance Programme with designated personnel and assure that the quality assurance responsibility is  being performed in compliance with these Principles of Good Laboratory Practice" [Section II.1.1(2f)]. In addition the test facility management should ensure "that the Study Director has made the approved study plan available to the Quality Assurance personnel" [Section II.1.1(2j)] and the responsibility of the Study Director should include ensuring "that the Quality Assurance personnel have a copy of the study plan and any amendments in a timely manner and communicate effectively with the Quality Assurance personnel as required during the conduct of the study" [Section II.1.2(2b)]. The test facility management should also ensure that “for a multi-site study that clear lines” of communication exist between the Study Director, Principal Investigator(s), the Quality Assurance Programme(s) and study personnel [Section II.1.1(2o)].



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Compliance of Laboratory Suppliers with GLP Principles

The responsibilities of the management of test facilities are defined in the OECD Principles of Good Laboratory Practice1 under the heading of Test Facility Organisation and Personnel (Section II.1). Test facility management should ensure that the GLP Principles are complied with at the test facility and that a sufficient number of qualified personnel, appropriate facilities, equipment and materials are available for the timely and proper conduct of the study. They also should ensure that test facility suppliers meet requirements
appropriate to their use in a study. On the basis of these requirements, suppliers of materials used in studies submitted to regulatory authorities need not be included in national GLP compliance programmes but they do play a definite role relating to the responsibilities of the  management of test facilities.

As by definition in the GLP Principles, the responsibility for the quality and fitness for use of equipment and materials rests entirely with the management of the test facility. The acceptability of equipment and materials in GLP-compliant laboratories should therefore be guaranteed to any regulatory authority to whom studies are submitted. The main purpose of this document is to offer advice to both test facility management and suppliers as to how they might meet GLP requirements through national  accreditation schemes and/or working to formal national or international standards, or by adopting other measures which may be appropriate to a particular product. National or international standards, which may be set by an accreditation organisation, may be applied whenever they are acceptable to the test facility’s management. The management of facilities, individually or in co-operation with each other, should thus maintain close contacts with  suppliers and with their accreditation organisations.


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