Good laboratory practice (GLP) is a standard by which laboratory studies are designed, implemented, and reported to assure the public that the results are correct and the experiment can be reproduced exactly, at any time in the future. In less technical terms, GLP is the cornerstone of all laboratory-based activities in any organization that prides itself on the quality of the work it performs. And, despite its immediate association with the pharmaceutical sector (Figure 1), GLPs can (and should) be applied to virtually all industries in which laboratory work is performed, including companies involved in drug manufacturing, food and drink production, and engineering. In addition, commercial testing laboratories (for toxicology, metabolism, materials and safety, for example), research establishments, and universities - in fact, all laboratories engaged in product or safety testing or research and development - should adopt and apply the doctrines of GLP.
GLP is not a luxury. It is a necessity for any professional laboratory wishing to gain and retain the respect of its employees, clients, regulators and perhaps most importantly, its competitors. If a company is seen to be applying and adhering to the highest standards of laboratory practice, it will gain significant competitive advantage and will compete successfully for business and recognition within its operational environment. Conversely, without rigidly enforced GLPs - and good manufacturing practices (GMPs) - a scientific organization will not achieve the commercial success and respect that its products and personnel deserve.
In December 1978, FDA published final GLP regulations and made compliance with them the law in the United States in June 1979. These regulations were collected in Title 21: "Food and Drugs" of the Code of Federal Regulations (CFR) as Part 58: "Good Laboratory Practice for Nonclinical Laboratory Studies," and they applied to all nonclinical safety studies intended to support research permits or marketing authorizations of products regulated by FDA. Subsequently, FDA's Office of Regulatory Affairs (ORA) released two Guidance for Industry documents to ensure the proper and consistent interpretation of the directives by industry and by FDA's field investigators. Further changes to the GLP rules were proposed in 1984, and in September 1987, FDA published its "Final Rule" - Compliance Program Bioresearch Monitoring: Good Laboratory Practices, which was expanded to incorporate the following:
Since then, the requirement for laboratories to apply and comply with GLP principles has extended from pharmaceutical companies to many other types of research and testing establishments throughout the developed world. In Europe, adherence to the principles of GLP is governed by European Union (EU) law and, in compliance with EU Directives, an inspection program confirms that "toxicological studies for the regulatory assessment of industrial chemicals, medicines, veterinary medicines, food and animal feed additives, cosmetics, and pesticides must be conducted in accordance with GLP."