What are Good Laboratory Practices (GLPs)?

June 8, 2026

Good Laboratory Practices (GLPs) are standards for nonclinical research studies. These standards must be met before the research data can be accepted and reviewed by a regulatory agency. A nonclinical study involves experiments to determine the safety of a product. But not in people! Nonclinical studies are performed before they are ever tested in people. Examples might be laboratory-based research, preclinical trials using animal models, toxicology assessments, or even environmental studies. Only after the product is confirmed to be safe will it be used in people.

The concept of GLP goes as far back as the 1940s, when it was developed in Australia. New Zealand and Denmark formally introduced them in 1972. The FDA put them into law in 1979. Today, GLP rules are enforced worldwide by many regulatory agencies.

Why do we need GLPs?

Unfortunately, you couldn’t always trust the data! Before GLPs, some laboratories were found to be manipulating results to favor a desired outcome. Other times, experiments were performed so poorly that the results could not be understood. GLPs provide the proper design, controls, and oversight to ensure the integrity of the data!

What might you test in a nonclinical study?

Nonclinical studies can be used to test many things. The study could be for a drug, a biological product, an electronic product, a medical device for people, or even a food additive.

Let’s use the example of testing the safety of a drug. Your study might aim to determine a dose and frequency that are safe. For dose, you might try 20 mg, 30 mg, and 50 mg. For frequency, you might try every day, every 2 days, or maybe once per week. Frequency and dose will be tested in different combinations for a specified amount of time, like a few weeks or months. Animal models such as mice, rats, or non-human primates are often used in nonclinical studies. The choice of animal species depends on the pharmacological relevance or metabolic profile of the drug. Observations and test results are documented in real-time throughout the study. At the end of the study, all the data together will show which doses and frequencies are safe, if any.

So, what kind of standards are needed for a GLP study?

A LOT! There are requirements for the people who perform the study, the laboratory, the equipment used, how the animals and even the data are handled. You also need to have a separate group of people who make sure the study was executed as planned, called the Quality Unit.

The people conducting the study need to have the right education, training, and experience. The laboratory must be the right size and in good condition. The equipment needs to be appropriate for the study, it needs to be calibrated and maintained, and people need to be trained on how to use it. Procedures must be available for handling study materials and samples so there are no mix-ups.

The Quality Unit must also oversee everything. They must approve the study protocol before it starts. They will review all of the data during the study, as well as at the end. The laboratory is regularly inspected by a regulatory agency (like the FDA). Only certain laboratories are authorized to conduct studies like this. These GLP standards must be maintained, too, or the laboratory can lose its authorization.

What do GLPs have to do with people with Ataxia?

Before clinical trials can begin, companies need to follow GLP standards to prove to regulators that their drugs are safe for human trials. If you are ever in a clinical trial to study the effectiveness of a drug to treat ataxia, you can rest assured that it has already been confirmed to be safe to take. Multiple well planned and controlled research studies need to be completed, reviewed, and accepted before a drug is tested in a human. GLPs ensure those studies are reliable.

In summary...

Nonclinical research studies must follow a set of rules (Good Laboratory Practices) when determining if a drug, a biological product, an electronic product, a medical device for people, or a food additive is safe for people. Without these rules, the safety data might not be trustworthy. These things must be deemed safe before people can use them!