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.

a) The OECD Principles of GLP concern “non-clinical” testing of a chemical or chemical product, examined under laboratory conditions or in the environment, including work conducted in greenhouses and in the field.  They do not include studies which use human subjects.

b) Examples of studies carried out under GLP include, inter alia:

i)      physical-chemical testing;

ii)     toxicity studies;

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)    studies on effects on mesocosms and natural ecosystems; and

viii)   analytical and clinical chemistry testing.

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.

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.

OECD countries in which non-clinical health and environmental safety testing is carried out according to the OECD Principles of GLP have established national GLP Compliance Monitoring Programmes (CMP) with responsibilities for monitoring GLP compliance of test facilities within their territories. GLP compliance is verified by CMPs through inspections of GLP test facilities, and audits of GLP studies. A test facility which has been subject to periodic inspections by a CMP, and found to be operating in compliance with the Principles of GLP, is recognised as a GLP compliant test facility.

In most countries, facilities that wish to become recognised as GLP compliant can apply to the national CMP. The CMP then conducts an inspection to determine if the test facility complies with the OECD Principles of GLP.  In other countries, CMPs can inspect any test facility claiming to conduct studies according to GLP.

OECD Principles of GLP

• No 1: OECD Principles on Good Laboratory Practice - Available in French, Spanish and German

GLP Consensus and Advisory Documents 

Consensus documents are guidance documents for the application of GLP that stemmed from ‘consensus workshops’ traditionally held in earlier years of the programme on particular issues regarding the application of GLP. These types of ‘consensus workshops’ are no longer held.

Advisory Documents are guidance documents for the application of GLP, formulated on a consensus-based approach and include a public consultation prior to the publication. Several documents have been updated as consensus documents or replaced by Advisory Documents through updated practices of the Working Party on GLP. 

• No 5: Compliance of Laboratory Suppliers with GLP Principles (revised in 1999) - Available in French, Spanish and German
• No 6: The Application of the GLP Principles to Field Studies (revised in 1999) - Available in French, Spanish and German 
• No 7: The Application of the GLP Principles to Short Term Studies (revised in 1999) - Available in French, Spanish and German
• No 8: The Role and Responsibilities of the Study Director in GLP Studies (revised in 1999) - Available in French and German 
• No 11: The Role and Responsibility of the Sponsor in the Application of the Principles of GLP (1998) - Available in French 
• No 12: Requesting and Carrying Out Inspections and Study Audits in Another Country (2002) - Available in French 
• No 13: The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Studies - Available in French and German  
• No 14: The Application of the Principles of GLP to in vitro Studies (2004)- Available in French 
• No 15: Establishment and Control of Archives that Operate in Compliance with the Principles of GLP (2007) - Available in French 
• No 16: Guidance on the GLP Requirements for Peer Review of Histopathology (2014)
• No 17: Application of GLP Principles to Computerised Systems (2016) - Available in German [Note: this document replaces Consensus Document No. 10. The document is also available in French, Spanish and German]
• No 17 Supplement 1: Advisory Document on GLP & Cloud Computing (2023)
• No. 19: Management, Characterisation and Use of Test Items (2018)
• No. 22: GLP Data Integrity (2021)
• No 23: Quality Assurance and GLP, second edition,  (See also Frequently asked questions: FAQ) [Note: this document replaces Consensus Document No. 4. The document is also available in French, Spanish and German]

Guidance Documents for Compliance Monitoring Authorities

Guidance for Compliance Monitoring Authorities is a sub-set of guidance specifically for the purposes of monitoring authorities.

• No 2: Revised Guides for Compliance Monitoring Procedures for Good Laboratory Practice (1995) - Available in French and Spanish
• No 3: Revised Guidance for the Conduct of Laboratory Inspections and Study Audit (1995) - Available in French and Spanish 
• No 9: Guidance for the Preparation of GLP Inspection Reports (1995) - Available in French and Spanish

Position Papers

Position papers are types of documents used to communicate advice on a specific topic when the topic is related to GLP but not directly linked to the implementation of the GLP principles. They are also used to communicate policy positions on topics from the viewpoint of the Working Party on GLP.

• The Use of Laboratory Accreditation with reference to GLP Compliance Monitoring (1994)
• Position Paper on 'Outsourcing’ of Inspection Functions by GLP Compliance Monitoring Authorities (2006)
• No. 18: OECD Position Paper Regarding the Relationship between the OECD Principles of GLP and ISO/IEC 17025 (2016) - Available in Turkish 
• No. 21: OECD Position Paper Regarding Possible Influence of Sponsors on Conclusions of GLP Studies (2020)
• No. 24: Position Paper on Quality Improvement Tools and GLP (2022)

Guidance for Receiving Authorities

Guidance for Receiving Authorities is a sub-set of guidance specifically for the purposes of government receiving authorities.

• No. 20: Guidance for Receiving Authorities on the Review of the GLP Status of Non-Clinical Safety Studies (2019)