Good Laboratory Practice

NAB-MALTA is the National Monitoring Authority responsible for verifying compliance with the principles of Good Laboratory Practice of any testing laboratory in Malta, claiming to use Good Laboratory Practice under L.N. 371 of 2004.

​Definition

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

The OECD Principles of GLP​ are followed by test facilities carrying out studies to be submitted to receiving authorities for the purposes of assessing the health and environmental safety of chemicals and chemical products which may also be of natural or biological origin and, in some circumstances, may be living organisms. The Principles of GLP define the responsibilities of test facility management, study director, study personnel and quality assurance personnel that are operating within a GLP system, and minimum standards concerning the suitability of facilities and equipment to perform studies, the need for standard operating procedures, documentation of raw data, study reports, the archiving of records, etc.

Applicable Regulations

The application of Good Laboratory Practice in safety testing of chemicals is required by the Directives 2004/09/EC and 2004/10/EC of the European Union. The implementation of the aforementioned European Directives in Malta is established in L.N. 371 of 2004​.

What types of tests are carried out at such facilities under GLP?

The OECD Principles of GLP concern non-clinical testing of a chemical or chemical product, examined under laboratory conditions or in the environment, including work conducted in greenhouses and in the field.  They do not include studies which use human subjects.

Some examples of studies carried out under GLP include:

Toxicity studies

Behavior in water, soil and air; bioaccumulation

Determination of pesticide residues in food or animal feedstuffs

Analytical and clinical chemistry testing

Mutagenicity studies

Physical-chemical testing

Environmental toxicity studies on aquatic and terrestrial organisms

Studies on the effects of mesocosms and natural ecosystems​ 

What type of chemicals/chemical products are covered by the OECD principles of GLP?

The OECD Principles of GLP apply to the non-clinical safety testing of test items contained in:

Pharmaceutical products

Pesticide products

Cosmetic products

Veterinary drugs

Food additives

Feed additives

Industrial chemicals​

Depending on the jurisdiction, the Principles of GLP may also be applied to non-clinical safety testing of other regulated products, such as medical devices.

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