Have you ever wondered why certain experiments are done under GLP (good laboratory practices) conditions? GLP is a term that is used frequently in preclinical research, and are a set of guidelines that act as a management control for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemicals (including pharmaceuticals) for non-clinical safety tests[1]. Sometimes it’s hard to understand when and why protocols must be done under GLP conditions. In general, GLP conditions must be maintained when an experimental drug or biologic may be used ultimately in humans and will need to be evaluated by regulators like the FDA.

Contemplate these questions to help you determine if you need to perform experiments under GLP. 

  1. What am I testing? Are you screening a panel of drugs or small molecules as potential therapeutics? If this is the case, then one or more of these candidate molecules may ultimately be used in a clinical trial, so you may consider doing assays under GLP conditions. If you are using experimental molecules to understand basic biology, then you probably do not need to use GLP-compliant protocols.
  2. Are you handling patient samples? Preclinical research is greatly enriched by the use of human samples because animal models are limited by what they can teach us about our own biology. But the use of samples from patients is carefully regulated in order to assure samples are used in line with the experimental protocol by which they were obtained. If a protocol has been designed to evaluate a potential treatment or diagnostic, patient samples may need to be handled under GLP conditions.
  3. Are you evaluating safety or toxicity of experimental drugs or biologics? Safety and toxicity evaluation is a critical element of preclinical research and must be performed under GLP conditions for regulatory compliance.

GLP-compliant protocols must be developed to satisfy specific criteria, and this process can be more costly and time-consuming than non-GLP protocols. Consider consulting with a GLP expert in order to assess your GLP needs. Proper planning can make the adaptation of GLP protocols more manageable and less overwhelming.

[1] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58