Good Laboratory Practice

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Good Laboratory Practice generally refers to a system of management controls for laboratories and research organisations to ensure the consistency and reliability of results as outlined in the Organisation for Economic Co-operation and Development (OECD) Principles of GLP and national regulations.

GLP applies to non-clinical studies conducted for the assessment of the safety of chemicals to man, animals and the environment. The internationally accepted definition is as follows:

Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals, agrochemicals, cosmetics, food and feed additives and contaminants, novel foods and biocides. GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.

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[edit] GLP and the FDA

The US FDA has rules for GLP in 21CFR58. These are the rules used for preclinical trials on animals prior to clinical research in humans. Research that is not conducted under these restrictions might be inadmissable in support of a New Drug Application in the US.

[edit] GLP and the European Union

Since 1987 the Council had adopted two basic Directives and a Decision relating to the application of the GLP principles. Directive 2004/10/EC has replaced Directive 87/017/EEC as of 11 March 2004; Directive 2004/9/EC has replaced Directive 88/320/EEC as of 11 March 2004

- " Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances."

Lays down the obligation of the Member States to designate the authorithies responsible for GLP inspections in their territory. It also comprises reporting and internal market (=mutual acceptance of data) requirements

- " Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP)". The Directive requires that the OECD Revised Guides for Compliance Monitoring Procedures for GLP and the OECD Guidance for the Conduct of Test Facility Inspections and Study Audits must be followed during laboratory inspections and study audits.

- 89/569/EEC Council Decision of 28 July 1989 on the acceptance by the European Economic Community of an OECD decision / recommendation on compliance with principles of good laboratory practice.

there are also 'Product Oriented Directives' refering to GLP obligations

  • Chemical substances (REACH)
  • Medicinal products
  • Veterinary Medicinal Products
  • Cosmetics
  • Feedingstuffs
  • Foodstuffs
  • Novel Foods and novel food ingredients
  • Pesticides
  • Biocides
  • Detergents

[edit] Notes and references

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[edit] See also

[edit] External links

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Organisation for Economic Co-operation and Development (OECD)
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