Good Laboratory Practice (GLP)

What is GLP?

Good laboratory practice (GLP) is a set of principles and guidelines that govern the operation of laboratories. GLP covers all aspects of laboratory operations, including the design and construction of laboratories, the selection and training of personnel, the conduct of experiments, the recording and reporting of data, and the storage and retrieval of samples. GLP is not a quality system or a product specification and therefore does not define specific outcome measures. Rather, GLP provides a system for ensuring that the data generated from laboratory studies are of high quality and suitable for their intended use.

The history of GLP.

The principles of GLP were first developed in the 1970s in response to concerns about the quality of data generated by laboratories contracted to support the safety evaluation of chemicals. The principles were formalized in a set of guidelines issued by the Organization for Economic Cooperation and Development (OECD) in 1981. The OECD guidelines are not legally binding, but they are widely recognized as the international standard for GLP.

In the United States, the Food and Drug Administration (FDA) has incorporated the principles of GLP into its regulations for the conduct of non-clinical laboratory studies. The FDA regulations are legally binding and apply to all studies conducted to support the safety evaluation of human and animal drugs, biologics, and medical devices.

The main GLP requirements:

• The management of the laboratory must ensure that qualified scientists work in appropriate facilities with appropriate equipment and materials. The qualifications of staff and the duties they perform must be recorded.
• The laboratories are required to establish quality control (QC). The quality control system should be documented and performed by the staff directly responsible for management. The quality control staff should not be involved in the studies.
• The study director has to agree with the plan and needs to seek authorization for any changes in the study plan.
• The laboratory workers must exercise safe working conditions, wear proper clothing for work, keep the workspace clean, label the workspace, stay focused and aware of their surroundings, and hand chemicals with suitable caution.
• The test facility should be suitable for the research performed to minimize outside conditions that could interfere with the validity of any results. 
• The substances for the studies should be kept in the proper facilities to avoid contamination. Waste disposal should not jeopardize the integrity of studies in progress. Waste collection, storage, and disposal facilities should be appropriate and the process of the waste collection must be documented.
• Sponsors and contract research organizations conducting non-clinical safety studies must comply with the U.S. law and regulations covering GLP.