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Good Laboratory Practice (GLP)

 

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One of the fundamental purposes of the Principles of Good Laboratory Practice (GLP) is to ensure the quality and integrity of test data related to non-clinical safety studies. The way in which study data, supporting human, animal and environmental safety assessment, is generated, handled, reported, retained and archived has continued to evolve in line with the introduction and ongoing development of supporting technologies. However, the main purpose of the requirements of the Principles of GLP remains the same in having confidence in the quality, the integrity of the data and being able to reconstruct activities performed during the conduct of non-clinical safety studies. This OECD Advisory Document on GLP Data Integrity provides guidance for test facilities or test sites that conduct GLP studies and aims to promote a risk-based approach to the management of data.

 

Countries' response to address the challenges posed by COVID-19 to GLP test facilities

Australia (NATA):

Updated Message to Australian GLP Test Facilities in May 2020 
Message to Australian GLP Test Facilities  in April 2020 

Belgium (Sciensano):

Guidance for GLP facilities in relation to the coronavirus (COVID-19)

Netharlands (IGJ):

The Health and Youth Care Inspectorate has published the following message on its website (in Dutch)
The Health and Youth Care Inspectorate has published the following message on its website (English translation version)

Slovakia (SNAS):

Guidance for Good Laboratory Practice (GLP) facilities in relation to the coronavirus (COVID-19)

Spain (Pharmaceuticals):

Information and clarifications for test facilities to address the challenges posed by COVID-19 in the field of GLP (in Spanish only)

UK (MHRA); 

Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak
Guidance for manufacturers and Good Practice (GxP) laboratories on exceptional flexibilities for maintenance and calibration during the coronavirus (COVID-19) outbreak
Guidance for Good Laboratory Practice (GLP) facilities in relation to coronavirus (COVID-19) 
New arrangements for MHRA Good Practice (GxP) inspections due to coronavirus (COVID-19) 
Blog MHRA Inspectorate

 

The Mutual Acceptance of Data (MAD) system

The OECD Principles of Good Laboratory Practice (GLP) ensure the generation of high quality and reliable test data related to the safety of industrial chemical substances and preparations. The principles have been created in the context of harmonising testing procedures for the Mutual Acceptance of Data (MAD).

 

Mutual Acceptance of Data

The MAD system helps to avoid conflicting or duplicative national requirements, provides a common basis for co-operation among national authorities and avoids creating non-tariff barriers to trade. OECD countries and full adherents have agreed that a safety test carried out in accordance with the OECD Test Guidelines and Principles of Good Laboratory Practice in one OECD country must be accepted by other OECD countries for assessment purposes. This is the concept of “tested once, accepted for assessment everywhere*”. This saves the chemicals industry the expense of duplicate testing for products which are marketed in more than one country. 

* While the receiving government must accept the study, how it interprets study results is its own prerogative. 

 

Did you know?

By reducing duplication, and creating a framework for the sharing of work, the MAD system saves governments and industry around € 309 million each year, as well as reduces the number of animals used in such testing.

 


 Good Laboratory Practice

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 Mutual Acceptance of Data (MAD)

    
 Documents


 OECD Council Acts related to MAD


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