GOOD LABORATORY PRACTICE

In the clinical and research arena, the phrase good laboratory practice or GLP generally refers to a system of management controls for laboratories and research organizations 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.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 become confused with the standards of laboratory safety - wearing appropriate gloves, glasses and clothing to handle materials safely.

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.

Definition

GLP is a quality system concerned with the organisational processing process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.

GLP ensures the quality, integrity, and reliability of safety data.

GLP principles include

1.Organization and Personnel

   Management-Responsibilities

   Sponsor-Responsibilities

   Study Director-Responsibilities

   Principle Investigator-Responsibilities

   Study Personnel-Responsibilities

2.Quality assurance program

   Quality Assurance Personnel

3.Facilities

   Test System Facilities

   Facilities for Test and Reference Items

4.Equipments, reagents and Materials

5.Test systems

   Physical/Chemical

    Biological

6.Test & Reference items

7.Standard operating procedures

8.Performance of Study

   Study Plan

   Conduct of Study

9.Reporting of results

10.Storage of Records and Reports