“Good Laboratory Practices” (GLP) mean much more than simply working carefully to derive accurate data.  The Code of Federal Regulations (21 CFR 58) states that for GLP compliance a laboratory must (among other things): 

  • Be open to inspection by the Food and Drug Administration. 
  • Have qualified personnel performing the tests. 
  • Have oversight by a Study Director. 
  • Use validated or compendial methods. 
  • Have an approved study protocol clearly defining objectives, methods, test site, and personnel. 
  • Have a designated Quality Assurance Unit overseeing the testing. 
  • Have facilities that are suitable for conducting the tests. 
  • Appropriately archive data. 
  • Maintain equipment that is appropriate for the testing. 
  • Appropriately calibrate the test equipment. 
  • Have documented Standard Operating Procedures (SOP) for the testing. 
  • Have documented purity and composition of test and control articles. 
  • Maintain proper storage of test and control articles. 
  • Retain records for up to five years.

When working with our clients who operate in a regulated environment, compliance with GLP regulations is essential.  Our team of scientists study the regs along with relevant ISO guidance documents for a particular sample type to ensure our protocols and reports are robust and will withstand rigorous audits.