“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.