Good Laboratory Practices (GLP) refers to a system where non-clinical health and safety studies are carried out, planned, monitored, recorded, archived and reported.
Between 1979 and 1980, the Organization for Economic Co-Operation and Development (OECD) member countries harmonized legislation to control chemical substances. The legislation requires manufacturers to perform laboratory studies and submit the results to a government authority for assessment of potential hazard to human health and the environment. The United States is a signatory to the act and these GLP standards and legislation and are published as part of the Code of Federal Regulations in the Federal Register.
GLP regulations subject organizations doing biotechnological research to rigid standards in order to produce quality test data. The idea was to build international standards to the point where test data is mutually acceptable among countries, avoiding duplication of effort and technical barriers to trade.
GLP standards [Harish C. Andola and Vijay Kant Prohibit], Good Laboratory Practice (GLP) Requirements: An Overview, New York Science Journal, 2010; 3(9) Pdf] are concerned with the organizational process and the conditions for performing laboratory studies and states:
- Management of the laboratory setting must ensure that qualified personnel work in appropriate facilities with appropriate equipment and materials. Records must be kept of qualifications of staff and the duties they perform.
- The standards require that laboratories establish a quality control (QC) system. The quality control system should be documented, and carried out by staff designated by and directly responsible to management. The quality control staff should not be involved in the studies being examined.
- The study director has to buy into the study plan and needs to seek authorization for any variation of the study plan.
- Personnel must exercise safe working conditions, handling chemicals with suitable caution. Personnel known to have a health condition should be excluded.
- The test facility should be of suitable size, construction and location to minimize outside conditions that could interfere with the validity of any results. The design of the facility should adequately separate the different activities to assure proper conduct of each study.
- Facilities for handling test and reference substances should be appropriately stored 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 waste collection should be documented.
- Apparatus, reagents and test systems should all be suitably located and of appropriate quality and design. Labeling should be exact. Records including details about test and reference substances should be maintained. Handling, sampling and storage procedures should be identified to assure homogeneity and stability. Containers should be carefully labeled.
- Sponsors and contract research organizations conducting non-clinical safety studies on investigational new drugs must comply with U.S. law and regulations covering GLP. The FDA uses the data to answer questions regarding toxicity, adverse effects, risks, teratogenic, carcinogenic, or other adverse effects and level of use that can be approved.
Acceptability of Non-GLP standards
The difference between GLP and non-GLP is that non-GLP studies do not require all of the rigor of GLP studies. Although GLP is written into the Official Register of the United States, compliance with GLP is not required for in vitro drug metabolism and drug interaction studies. Compliance to GLP requirements is not required for discovery, basic research, screening or other studies where the safety of a product is not being assessed. GLP is required for extrapolation to humans. Non-GLP studies can be of high quality for any other purpose.
In many studies where GLP compliance is not required and for which the intensive reporting requirements and facility requirements could be an impediment, non-GLP options can represent an advantage. Quality assurance does not have to inspect the conduct of non-GLP studies or records. Analysis of the concentration of test article dosing solutions is not required in non-GLP studies. Alternatives to a complete study reports, like data summaries, are acceptable in non-GLP studies. Methodological validation by quality control is not required for Non-GLP studies.
HSRL, Inc. provides GLP and non-GLP services to other contract research organizations, drug discovery, biotechnology, medical device and pharmaceuticals companies, clinics, academic institutions and government agencies. Please contact us for more information.