Good laboratory practice

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 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.

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.

Safe laboratory practice

It is important to be safe when working in a laboratory. Wear personal protective equipment (PPE) such as goggles, gloves or respiratory protection and be safe.

Avoid exposure to hazardous material by planning all procedures before starting any laboratory work.

The production of aerosols due to poor technique (squirting the last drop out of pipettes) and the spread of contamination due to spills is completely avoidable and especially important if you are handling infectious material, radiochemicals, carcinogens or highly toxic material.

Keep stocks of reagents and solvents in the laboratory to a minimum, this reduces the risk of wastage due to contamination, it reduces the potential fire load and reduces the potential for harm.

See also

• Good Laboratory Practices in India
• GxP
• Organisation for Economic Co-operation and Development (OECD)
• Joint Committee for Traceability in Laboratory Medicine
• International Laboratory Accreditation Cooperation
• International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)
• Drug development
• ISO 15189

External links

• Good Laboratory Practice (Organisation for Economic Co-operation and Development)
• OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring