The term Good Laboratory Practice (GLP) is a well known acronym for quality in the laboratory. It is a standard by which laboratory studies are designed, implemented and reported to assure the public that the results are accurate/reliable and the experiment can be reproduced accordingly, at any time in the future. But how much do you know about the term and its background?
OK, let’s start from the beginning: Good Laboratory Practice is a formal regulation that was created in 1978 when the FDA (US Food and Drug Administration) released a set of guidelines intended to create a verifiable testing record in laboratory testing throughout the United States. GLP was intended to regulate non-clinical laboratory safety studies (i.e., animal toxicology testing) to ensure that any new molecular entities developed by the pharmaceutical industry were safe before administration to human volunteers and patients in clinical trials. For this reason, the term GLP is most commonly associated with the pharmaceutical industry and the required non-clinical animal testing that must be performed prior to approval of new drug products. However, GLP applies to virtually all industries in which laboratory work is conducted, including companies involved in manufacturing, foods, pesticides (agrochemicals), drink production, and engineering testing.
In addition to the FDA regulations, the Organization for Economic Cooperation and Development (OECD) adopted principles of Good Laboratory Practice, which are accepted within the Community and are specified in the European Parliament and Council Directive 2004/10/EC of 11 February 2004. The Directive states: “The application of standardised organisational processes and conditions under which laboratory studies are planned, performed, recorded and reported for the nonclinical testing of chemicals for the protection of man, animals and the environment, hereinafter referred to as ‘Good Laboratory Practice’ (GLP), contributes to the reassurance of Member States as to the quality of the test data generated” and goes on to say “Mutual recognition of the results of tests obtained using standard and recognised methods is an essential condition for reducing the number of experiments in this area. However, in order to ensure that test data generated by laboratories in one Member State are also recognised by other Member States, it is necessary to provide for a harmonised system for study audit and inspection of laboratories to ensure that they are working under GLP conditions”.
The key requirements of a GLP type works are
- Responsibilities should be defined for the sponsor management, for the study management, and for the quality assurance unit.
- All routine work should follow written standard operating procedures.
- Facilities such as laboratories should be large enough and have the right construction to ensure the integrity of a study, for example, to avoid cross contamination.
- Test and control articles should have the right quality and instruments should be calibrated and well maintained
- People should be trained or otherwise qualified for the job
- Raw data and other data should be acquired, processed and archived to ensure integrity of data.
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. However, advanced quality laboratories do not merely satisfy Good Laboratory Practice requirements.
In fact, while GLP standards remain a mandatory fixture of reliable laboratory testing, an advanced quality laboratory is not satisfied with data integrity alone. According to us, the difference comes down to the advanced quality laboratory’s pervasive and tireless commitment to continual improvement—not only in data integrity, but also in safety, responsibility and innovation.