What are GLP Regulations?

What are GLP Regulations?

GLP regulations
GLP regulations maintain the quality and honesty of research laboratories ensuring consistency and integrity of non-clinical safety tests. Testing helps to ensure safe products enter the marketplace for consumer consumption.

GLP regulations (Good Laboratory Practices), are a series of guidelines set forth to maintain quality and honesty of research laboratories. This ensures consistency, quality and integrity of non-clinical safety tests. One of GLPs most common applications is in the pharmaceutical industry where animal testing new drug products is a requirement.

Two common misconceptions regarding GLP regulations exist. One is that they apply to clinical studies, which is not true. GLPs only apply to non-clinical studies and tests, whereas clinical studies are overseen by GCP (Good Clinical Practices) and other regulations. Two is that GLPs is a scientific management system which is also false. GLP is a quality management system, meaning it sets standards relating to the study, conduct, collection of data, and reporting of results, it does not set or define scientific standards. A key component of GLP regulations is that it has a Quality Assurance (QA) unit whose purpose is to monitor the study and verify all procedures followed,  instilling confidence in the study.

The following are test requests Contract Laboratory has received for testing and studies under GLP guidelines:

  • Bioscience company needs laboratory for OPPTS thermal explodability (for liquids) and impact explodability (for solids) testing of three compounds (two liquids & one solid) under GLP guidelines and the testing guidelines are OPPTS 830.6316, Explodability
  • EPA GLP microbiology laboratory needed for viral efficacy of chlorine dioxide solution for Avian Polyomavirus (APV) for EPA registration
  • LONG-TERM TESTING FDA GLP textiles laboratory needed for testing to provide profilometry data on our fabric samples used in medical / performance clothing products.
  • Food microbiology laboratory needed for GLP antiviral testing of disinfectants against poultry viruses
  • Manufacturer needs GLP approved tests of organic agriculture pesticides to be in compliance with exportation regulation
  • FDA GLP Medical Device Laboratory needed for performance testing of medical resuscitator to ISO 10651-4 Manual Resuscitator. The tests include: O2 concentration – Expiratory resistance – Inspiratory resistance – Patient valve – (Dead space – Tidal Volume)
  • Agriculture laboratory needed for copper determination of a technical grade pesticide by a GLP analysis with electrogravimetrical analysis
  • FDA GLP bioanalytical laboratory needed for bioanalysis of bovine IgA content of spray-dried bovine plasma, whey protein, and animal feed (containing bovine plasma/whey protein) by HPLC chromatography. The samples would consisting of 1 plasma sample, 3 whey samples, and 3 animal feeds.
  • View more of our recent test requests, here!

Need a laboratory to perform your testing according to GLP regulations? We can help! Submit your product, study, or non-clinical GLP test request on our website, or by calling 1-855-377-6821 today!