Warning: Creating default object from empty value in /home4/sspccco/public_html/pharmafacts.com/plugins/system/J2top.php on line 78
OECD Guidances - PharmaFacts
If you don't find what you're looking for, please let us know.

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

Warning: Creating default object from empty value in /home4/sspccco/public_html/pharmafacts.com/plugins/system/modulesanywhere.php on line 159

The Application of the GLP Principles to Field Studies

The Principles of Good Laboratory Practice (GLP), as adopted by the OECD in 1981 and revised in 1997, provide recommended test management standards for a wide variety of studies done for regulatory purposes or other assessment-related purposes. The report of the Expert Group1 which developed the GLP Principles in 1981 expressly lists the following types of tests as covered by the GLP Principles:
· physico-chemical properties;
· toxicological studies designed to evaluate human health effects (short- and long-term);
· ecotoxicological studies designed to evaluate environmental effects (short- and long-term);
· ecological studies designed to evaluate environmental chemical fate (transport, biodegradation, and bioaccumulation).

Testing intended to determine the identity and magnitude of pesticide residues, metabolites, and related compounds for tolerance and other dietary exposure purposes is also included in the overall classification of ecological studies.  The GLP Principles are intended to cover a broad range of
commercial chemical products including pesticides,  pharmaceuticals, cosmetics, veterinary drugs as well as food additives, feed additives and industrial chemicals.



Warning: Creating default object from empty value in /home4/sspccco/public_html/pharmafacts.com/plugins/system/modulesanywhere.php on line 159

The Application of the GLP Principles to Short Term Studies

The OECD Principles of GLP are general and not specific to any particular type of test or testing discipline. The initial experience in OECD Member countries in compliance monitoring has been primarily in long-term toxicity studies. Although subject to the OECD Principles of GLP, short-term studies present special concerns to management and compliance monitoring authorities based upon the existence of particular procedures and techniques.

The Revised Principles of GLP define a short-term study as “a study of short duration with widely used, routine techniques” [I.2.3.2]. Short-term biological studies include acute toxicity studies, some mutagenicity studies, and acute ecotoxicological studies.

Physical-chemical studies are those studies, tests or measurements which are of a short duration (typically not more than one working week), employ widely-used techniques (e.g. OECD Test Guidelines) and yield easily repeatable results, often expressed by simple numerical values or verbal expressions.

Typical physical-chemical studies include but are not limited to chemical characterisation studies, melting point, vapour pressure, partition coefficient, explosive properties and other similar studies for which test guidelines exist. However, the regulatory agencies/receiving authorities in Member countries will specify which of these tests should be submitted to them and which should be conducted under the Principles of GLP.



Warning: Creating default object from empty value in /home4/sspccco/public_html/pharmafacts.com/plugins/system/modulesanywhere.php on line 159

The Role and Responsibilities of the Study Director in GLP Studies

The Study Director represents the single point of study control with ultimate responsibility for the overall scientific conduct of the study. This is the prime role of the Study Director, and all duties and responsibilities as outlined in the GLP Principles stem from it. Experience has shown that unless responsibility for the proper conduct of a study is assigned to one person, there is a potential for personnel to receive conflicting instructions, which can result in poor implementation of the study plan. There can be only one Study Director for a study at any given time. Although some of the duties of the Study Director can be delegated, as in the case of a subcontracted study, the ultimate responsibility of the Study Director as the single central point of control cannot.

In this regard, the Study Director serves to assure that the scientific, administrative and regulatory aspects of  the study are controlled. The Study Director accomplishes this by coordinating the inputs of management, scientific/technical staff and the Quality Assurance programme.

In multi-site studies which involve work at more than one test site and the Study Director cannot exercise  immediate supervision, study procedures may be  controlled by an appropriately trained, qualified and  experienced member of the staff, called the Principal  Investigator. He is responsible for the conduct of certain defined phases of the study in accordance with the applicable Principles of Good Laboratory Practice, acting on behalf of the Study Director. Scientifically, the Study Director is usually the scientist responsible for study plan design and approval, as well as overseeing data  collection, analysis and reporting. The Study Director is responsible for drawing the final overall conclusions from the study. As the lead scientist, the Study Director must
coordinate with other study scientists, and/or Principal Investigator(s) keeping informed of their findings during the study and receiving and evaluating their respective individual reports for inclusion in the final study report. Administratively, the Study Director must request and coordinate resources provided by management, such as personnel, equipment and facilities, to ensure they are adequate and available as scheduled for the proper conduct of the study.

Compliance with regulations is also the responsibility of the Study Director. In this role the Study Director is responsible for ensuring that the study is carried out in accordance with the Principles of GLP, which require the Study Director’s signature on the final study report to confirm compliance with the GLP Principles.



Warning: Creating default object from empty value in /home4/sspccco/public_html/pharmafacts.com/plugins/system/modulesanywhere.php on line 159

Guidance for the Preparation of GLP Inspection Reports

One of the goals of the work of the OECD Panel on Good Laboratory Practice is to facilitate the sharing of information from GLP compliance monitoring programmes conducted by Member countries. This goal requires more than the promulgation of enforceable principles of GLP and the conduct of an inspection programme by the national monitoring authority. It is also necessary to have the reports of the inspections prepared in a useful and consistent manner. The Guidance for the Preparation of GLP Inspection Reports developed by the Panel on GLP set forth below suggests elements and/or concepts that can  contribute to a useful report of a GLP inspection and study audit. It may be used by Member countries as a component of their compliance monitoring programme.



Warning: Creating default object from empty value in /home4/sspccco/public_html/pharmafacts.com/plugins/system/modulesanywhere.php on line 159

The Application of the Principles of GLP to Computerised Systems

Throughout recent years there has been an increase in the use of computerised systems by test facilities undertaking health and environmental safety testing. These computerised systems may be involved with the direct or indirect capture of data, processing, reporting and storage of data, and increasingly as an integral part of automated equipment. Where these computerised systems are associated with the conduct of studies intended for regulatory purposes, it is essential that they are developed, validated, operated and maintained in accordance with the OECD Principles of Good Laboratory Practice (GLP).


More Articles...