Good Laboratory Practice (GLP) refers to a system of federal regulations revolving around the planning, monitoring, conducting, and reporting of non-clinical health and safety studies. GLP compliance ensures companies that submit safety data for regulatory approval follow strict standards of integrity, reliability, and validity throughout their processes.
GLP compliance is essential for many different operations, but it isn’t necessary for every non-clinical study. Learning the difference between GLP and non-GLP studies allows you to make informed choices as you navigate the research process.
GLP Compliance Requirements
GLP compliance seeks to build strict international standards that help make test data acceptable across multiple countries. Because of this, GLP regulations revolve around the organization, processes, and conditions of laboratory studies.
When a study meets GLP standards, that means there is thorough documentation of all standard operating procedures. Additionally, the lab performing the study has undergone quality assurance inspections regarding the study itself, the lab’s processes, and the overall facility where the study took place.
When Is GLP Mandatory?
The main difference between GLP and non-GLP studies is the assessment of safety. The FDA requires GLP compliance for non-clinical laboratory studies that seek to prove the safety of products such as food, animal drugs, human drugs, biological products, medical devices, and more. Studies that revolve around toxicity profiles, adverse effects, or safe levels of use must comply with GLP standards.
However, if a non-clinical laboratory study doesn’t seek to prove or assess safety, it doesn’t need to meet GLP regulations. Basic research, screenings, discovery studies, and other similar endeavors can still deliver high-quality results and information without meeting FDA standards for Good Laboratory Practices.
Reliability in Non-GLP Studies
Non-clinical laboratory studies that do not face GLP requirements still strive to meet a high level of quality and accountability. Non-GLP studies prioritize documentation, conduct safe and responsible procedures, and present reviewed, reliable data at the end of each study.
There is no right or wrong answer when choosing between GLP and non-GLP studies. In some scenarios, non-GLP procedures offer the standard of quality you need with a shorter timeframe and lower price. However, some studies require the strict attention and care of GLP regulations. By partnering with a contract development and manufacturing organization you can trust, you get the most out of your project no matter which option you choose.
Moravek has the resources and expertise to conduct custom radiolabeling projects with a high standard of quality and care. Learn more about our techniques and procedures when you work with the team at Moravek today.