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 (only preclinical studies), agrochemicals, cosmetics, food additives, feed additives and contaminants, novel foods, biocides, detergents etc.... 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.

GLP can be confused with the standards of laboratory safety - wearing appropriate gloves, glasses and clothing to handle materials safely.

Contents

[edit] GLP and the OECD

Following Decision C(97),186/Final of the OECD Council, data generated in the testing of Chemicals in one OECD Member Country, in accordance with OECD Test Guidelines and the Principles of GLP are accepted in all other OECD Member Countries.

[edit] GLP and the FDA

The US FDA has rules for GLP in 21CFR58. These are the rules used for preclinical trials in US on animals prior to clinical research in humans. Research in US that is not conducted under these restrictions or research done outside US that is not conducted according to the OECD Guidelines (or FDA rules) might be inadmissible 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."

This directive lays down the obligation of the Member States to designate the authorities responsible for GLP inspections in their territory. It also comprises reporting and internal market (i.e., 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' referring to GLP obligations:

  • Chemical substances; Regulation (EC) N° 1907/2006 (also known as the "Evaluation, Authorisation and Restriction of Chemicals" Regulation, or "REACH" regulation) of 18 December 2006 and Directive 2006/121/EC of 18 December 2006
  • Medicinal products; Directive 2001/83/EC on the Community code relating to medicinal products for human use of 6 November 2001 as amended by Commission Directive 2003/63/EC
  • Veterinary Medicinal Products; Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products
  • Cosmetics; Council Directive 93/35/EEC amending for the 6th time directive 76/768/EEC
  • Feedingstuffs; Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition
  • Foodstuffs; Directive 89/107/EEC
  • Novel Foods and novel food ingredients; Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients
  • Pesticides; Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market
  • Biocides; Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market
  • Detergents; Directive 98/8/EC Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents
  • EC Ecolabel; Commission Decision 2005/344/EC of 23 March 2005; establishing ecological criteria for the award of the Community eco-label to all-purpose cleaners and cleaners for sanitary facilities

In the mean time the EU has concluded Mutual Acceptance Agreements in the area of GLP with Israel, Japan and Switzerland. By means of the Treaty of the European Economic Area of 13 September 1993, the European Regulations and Directives also apply to Iceland, Liechtenstein and Norway.

[edit] GLP and the non-member countries

An inspection in non-member economies by OECD inspectors will not guarantee that, if they are found to be in compliance, their data will be accepted in other member countries than the one to which they are submitting data and which has thus sent inspectors to verify the accuracy of their compliance statement.

[edit] GLP and automated system

Implementing GLP on an automated system is always an intellectual and labour-intensive task which requires to make a great amount of effort by a GxP company. To ease the burden of this management, Webster et al. have provided a fairly good tutorial for users to quickly embark on and do the job properly [1].

[edit] Notes and references

  1. ^ Webster, Gregory K. et al. (2005). "JALA Tutorial: Considerations When Implementing Automated Methods into GxP Laboratories". Journal of the Association for Laboratory Automation (Elsevier) 10 (3): 182 - 191. doi:10.1016/j.jala.2005.03.003. 

[edit] See also

[edit] External links

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Organization for Economic Co-operation and Development (OECD)
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