OECD PRINCIPLES OF GLP PPT : The Organisation for Economic Co-operation and Development

Presented by
JAI PRAKASH SINGH
M.Pharm IInd sem Pharmacology
Raj Kumar Goel Institute of Technology (Pharmacy)
A Seminar
On
Topic: OECD Principles of GLP
PTSM-2
(Date:) 21/05/2024

CONTENT
 Introduction of OECD (The Organisation for Economic Co-operation
and Development)
 Origin of OECD
 OECD Principle of GLP
 What types of Tests Carried out under GLP
 Chemicals/Chemicals product covered by OECD Principles of GLP

OECD: THE ORGANISATION FOR ECONOMIC CO-OPERATION
AND DEVELOPMENT
OECD is an intergovernmental organization located in Paris, France
 Ambassador Sean Patrick Maloney took up his duties as Permanent
Representative of the United States to the OECD on 2 April 2024.
The Principle of GLP have been developed to promote the quality and
validity of test data used for determining the safety of chemicals and
chemicals products.
In 1979 and 1980, an international group experts established under the
special Programme on the control of Chemicals developed the “OECD
Principle of GLP”

 These principles of GLP were adopted by OECD Council in 1981.
 Revised in 1996 and reviewed on 26th Nov 1997
 The OECD’s 38 members are: Austria, Australia, Belgium, Canada, Chile,
Colombia, Costa Rica, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Japan, Korea,
Latvia, Lithuania, Luxembourg, Mexico, the Netherlands, New Zealand,
Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden,
Switzerland, Turkey, the United Kingdom and the United States.
 India is one of the many non-member economies with which the OECD has
working relationships in addition to its member countries. The OECD has
been co-operating with India since 1995.

ORIGIN OF OECD
 On 16 April 1948, The Organisation for European Economic
Co-operation (OEEC) was born.
 The Convention transforming the OEEC into a new
organisation was signed at the Château de la Muette in Paris
on 14 December 1960. It was the beginning of a new era: the
Organisation for Economic Co-operation and Development
came into being on 30 September 1961.

OECD PRINCIPLES OF GOOD LABORATORY PRACTICE
(GLP)
 The Principles of Good Laboratory Practice (GLP) are a managerial quality control
system covering the organisational process and the conditions under which non-
clinical health and environmental studies are planned, performed, monitored,
recorded, reported and retained (or archived).
 The OECD Principles of GLP are followed by test facilities carrying out studies to
be submitted to receiving authorities for the purposes of assessing the health and
environmental safety of chemicals and chemical products which may also be of
natural or biological origin and, in some circumstances, may be living organisms.
 The Principles of GLP define the responsibilities of test facility management, study
director, study personnel and quality assurance personnel that are operating within a
GLP system, and minimum standards concerning the suitability of facilities and
equipment to perform studies, the need for standard operating procedures,
documentation of raw data, study reports, the archiving of records, etc.

OECD PRINCIPLES OF GLP
 The OECD (Organization for Economic Co-operation and Development) Principles of Good Laboratory
Practice (GLP) are a set of standards that ensure the quality and integrity of non-clinical laboratory
studies. These principles are internationally recognized and provide a framework for the organization and
management of testing facilities, as well as the conduct of studies. Here are the key components of the OECD
Principles of Good Laboratory Practice:
 1. Quality Assurance: GLP emphasizes the importance of quality assurance systems to ensure that studies are
conducted consistently, accurately, and in compliance with regulatory requirements.
 2. Organization and Personnel: Testing facilities must have adequate organizational structures and qualified
personnel to carry out studies effectively. This includes having designated roles and responsibilities, training
programs, and procedures for personnel selection.
 3. Facilities: GLP requires testing facilities to have suitable and well-maintained facilities, equipment, and
resources necessary for conducting studies.
 4. Equipment: Adequate calibration, maintenance, and validation of equipment used in studies are essential to
ensure reliable and accurate results.

 5. Test and Control Items: GLP specifies requirements for the receipt, handling, storage, and documentation of
test and control items used in studies to prevent contamination and ensure traceability.
 6. Standard Operating Procedures (SOPs): Testing facilities must develop and maintain SOPs for all aspects
of study conduct, including experimental procedures, data recording, and reporting.
 7. Study Plan: A detailed study plan must be developed before the initiation of any study, outlining the
objectives, methodology, procedures, timelines, and data analysis methods.
 8. Data Integrity and Reporting: GLP emphasizes the importance of accurate and complete data recording,
storage, and reporting. All data must be traceable, and any deviations or anomalies must be documented and
explained.
 9. Archiving: Testing facilities are required to archive study documentation, raw data, and samples for a
specified period to allow for traceability and auditability.
 10. Inspections and Audits: Regulatory authorities conduct inspections and audits of testing facilities to ensure
compliance with GLP standards and regulatory requirements.

WHAT TYPES OF TESTS ARE CARRIED OUT AT SUCH FACILITIES
UNDER GLP?
 a) The OECD Principles of GLP concern “non-clinical” testing of a chemical or
chemical product, examined under laboratory conditions or in the
environment. They do not include studies which use human subjects.
 b) Examples of studies carried out under GLP include,
 i) physical-chemical testing; (TG408)
 ii) toxicity studies; (TG407, TG452, TG412, TG443)
 iii) mutagenicity studies;
 iv) The environmental toxicity studies on aquatic and terrestrial organisms
 v) studies on behaviour in water, soil and air; bioaccumulation
 vi) studies to determine pesticide residues in food or animal feedstuffs
 vii) analytical and clinical chemistry testing

WHAT TYPES OF CHEMICALS/CHEMICAL PRODUCTS ARE COVERED
BY THE OECD PRINCIPLES OF GLP?
 The OECD Principles of GLP apply to the non-clinical safety testing of test
items contained in:
 i) pharmaceutical products;
 ii) pesticide products;
 iii) cosmetic product;
 iv) veterinary drugs;
 v) food additives;
 vi) feed additives; and
 vii) industrial chemicals
Depending on the jurisdiction, the Principles of GLP may also be applied to
non-clinical safety testing of other regulated products, such as medical
devices.

HOW DO GOVERNMENTS VERIFY THAT A STUDY CONDUCTED AT A
TEST FACILITY WAS CARRIED OUT ACCORDING TO THE OECD
PRINCIPLES OF GLP?
Data on safety testing have to be submitted to receiving authorities for
marketing authorisation of the product. As part of the review process
GLP compliance of the submitted data is verified. In addition,
the GLP compliance status of the test facility at which the study was
carried out, is checked by consulting information on inspections
provided by the national GLP compliance monitoring programmes.

REFERENCES
1.OECD Principles of GLP [cited 2024 May]. Available from:
https://www.oecd.org/chemicalsafety/testing/overview-of-good-laboratory-practice.htm
2.Oecd history [cited 2024 May]. Available from: https://www.oecd.org/about/history/oeec/

OECD PRINCIPLES OF GLP PPT : The Organisation for Economic Co-operation and Development

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