Good Laboratory Practice

Prior to 1976 the data from laboratory studies used to support agrochemical registrations were taken mainly on trust by government authorities. However, in 1976 during a routine audit, the US Food and Drug Administration (FDA) uncovered discrepancies between raw data and reports on toxicology studies at Industrial Bio-Test Laboratories in Chicago. Many of the discrepancies related to poor record keeping, insecure animal housing, inadequate planning and incompetent execution of studies, insufficient documentation of methods and results and even fraud.

This finding gave a major impetus for the introduction of Good Laboratory Practice (GLP), initially for toxicology studies, by the FDA in the US in the late 1970s. In the US the EPA followed the lead of the FDA and in 1983 instituted Good Laboratory Practice requirements for studies required to evaluate health and environmental effects for new and existing chemicals.

Good Laboratory Practice stresses the importance of the following main points¹ :

Resources : Organisation, Personnel, Facilities, Equipment

Rules : Protocols, Standard Operating Protocols (SOPs), Study Director as pivotal point of study control

Characterisation : Test items, test systems

Documentation : Raw data, Final report, Archives

Quality Assurance : Independent from study conduct

Internationally the observance of GLP has been defined as a prerequisite for the mutual acceptance of data, which means that different countries or regulatory authorities accept laboratory studies from other countries as long as they follow the internationally accepted GLP principles. In order to facilitate further the mutual acceptance of data and to extend this possibility to outside countries, the OECD Council adopted, on 26 November 1997, the 'Council Decision concerning the Adherence of Non-member Countries to the Council Acts related to the Mutual Acceptance of Data in the Assessment of Chemicals' [C(81)30(Final) and C(89)87(Final)] [C(97) 114/Flnal), wherein interested non-member countries are given the possibility of voluntarily adhering to the standards set by the different OECD Council Acts and thus, after satisfactory implementation, to join the corresponding part of the OECD Chemicals Programme. Mutual acceptance of conformity of test facilities and studies with respect to their adherence to GLP, on the other hand, necessitated the establishment of national procedures for monitoring compliance. According to the OECD Council 'Decision-Recommendation on Compliance with Principles of Good Laboratory Practice' of 2 October 1989 [C(89)87(Final)), these procedures should be based on nationally performed laboratory inspections and study audits. The respective national compliance monitoring authorities should exchange not only information on the compliance of test facilities inspected, but should also provide relevant information concerning the countries' procedures for monitoring compliance. Although devoid of such officially recognised national compliance monitoring authorities, some developing countries do have an important pharmaceutical industry, where preclinical safety data are already developed under GLP. In these cases, individual studies are - whenever necessary - audited by foreign GLP inspectors e.g. of FDA, the Netherlands or Germany⁽¹⁾.

Information on the current status of GLP can be found on the OECD², FDA^3, EPA4 and EU⁵ websites. Information from individual countries is also available on the web e.g. the UK⁶, Germany⁷ and Japan⁸.

References

1.     Handbook, Good Laboratory Practice (GLP), Quality Practices for Regulated Non-Clinical Research and Development, UNDP/World Bank/WHO

http://www.who.int/tdr/publications/publications/pdf/glp-handbook.pdf

2.     OECD Good Laboratory Practice

http://www.oecd.org/department/0,2688,en_2649_34381_1_1_1_1_1,00.html

3.     US FDA, Code of Federal Regulations Title 21, Good Laboratory Practice for Nonclinical Laboratory studies

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=58

4.     US EPA, Compliance and Enforcement, Good Laboratory Practice

http://cfpub.epa.gov/compliance/resources/policies/glp/

5.     European Commission, Enterprise and Industry, Chemicals, Good Laboratory practice - GLP

http://ec.europa.eu/enterprise/sectors/chemicals/documents/classification/laboratory-practice/#h2-glp-directives

6.     UK Medicines and Healthcare Products Regulatory Agency, Good Laboratory Practice, Publications

http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodLaboratoryPractice/Publicationsandapplicationform/index.htm

7.     BfR Federal Institute for Risk Assessment, GLP Federal Bureau

http://www.bfr.bund.de/cd/1488

8.     Japan Food and Agricultural Materials Inspection center, GLP Compliance

http://www.acis.famic.go.jp/eng/glp/index.htm

Last modified 2^nd April 2010