Good Laboratory Practice (GLP)

What is good laboratory practice?

Good laboratory practice (GLP) is a quality system that provides a framework for conducting well-controlled studies. It encompasses the organizational processes and conditions in which non-clinical laboratory studies are planned, performed, recorded, monitored, reported, and archived. It ensures that test data submitted to the government for a research permit is of high quality and integrity.

GLP differs from current good manufacturing practice (CGMP), which applies to the entire drug manufacturing process. In comparison, GLP only applies to the safety testing. However, like CGMPs, GLPs are also enforced by the U.S. Food and Drug Administration (FDA).

GLP guidelines include:

  • The appointment of a study director who is responsible for GLP compliance
  • Separation of activities at the testing facility to prevent interference
  • Periodic calibration of all equipment used in the study (records of calibration should be retained)
  • Personnel should know specific information about each test and control article (e.g., identity, composition, stability, date of receipt, storage instructions, quantity received)
  • Study plan or protocol
  • Standard operating procedures (SOPs)
  • Creation of a final report

How does GLP improve healthcare?

The GLP framework helps ensure the quality and integrity of the collected data, provides overall accountability, and facilitates study reconstruction. It ensures that chemicals are consistently safe and reliable and keeps those working in the lab safe as they create life-saving medications or medical devices.