Laboratories, whether clinical or non-clinical, have to follow certain Good Laboratory Practices (GLP). Nonclinical laboratories, that is a lab not in a clinical setting, have additional rules they must follow as part of GLP. In the US, it is the FDA that sets the guidelines and regulations for these non-clinical labs to follow. Manufacturers of pharmaceuticals, medical devices, or other regulated products should remain up to date on these practices so that if they need to work with a lab they can find one that is compliant with the regulations. Pharmaceutical manufacturers may have an in-house lab, in which case they also need to follow the practices set by the FDA.

The FDA sets Good Laboratory Practices in nonclinical laboratory studies in 21 CFR part 58.[1] This part details the requirements for the studies including the facility requirements and personnel requirements. Manufacturers need to find labs that meet these requirements. Working with a lab that does not meet the requirements for testing of products, such as performance testing of a medical device, could lead to the FDA rejecting the study and labeling the study as invalid. This would then lead to delays in a product being approved for market.

Record keeping is a large part of GLP. Everything from the method of how a test was performed to the cleaning done before and after should be recorded. Those who performed the tests and those who performed a check of the results should both sign off and date the test reports. Any circumstances that could have affected the integrity of the results should also be recorded. This would include conditions such as high or low temperatures.  These records must be maintained according to the guidelines set in Part 58.

Laboratories regulations share many similarities with manufacturing regulations, the differences, however, are critical. When trying to find a compliant lab it is important to remember the GLPs that they must follow. EMMA International can help identify compliant laboratories that can meet your testing needs. EMMA International can also help laboratories meet all necessary GLPs, including creating a quality management system. EMMA International provides Full Circle Consulting services, give us a call at 248-987-4497 or email us at info@emmainternational.com to get in touch with our team of experts today.


[1] FDA (July 2021) Nonclinical Laboratories Inspected under Good Laboratory Practices, Retrieved 4/16/2022 from https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/nonclinical-laboratories-inspected-under-good-laboratory-practices

Gabe Kadoo

Gabe Kadoo

Mr. Kadoo is a Quality Engineer at EMMA International. He has experience in statistical analysis, performance improvement, quality assurance, and value stream mapping in the clinical setting. Mr. Kadoo also has experience as a clinical researcher and medical technologist. Mr. Kadoo holds a Bachelor of Science in Biology and a Master of Public Administration with a concentration in Healthcare Administration. He is also a Six Sigma Green Belt.

More Resources

FDA Adverse Event Reporting 

FDA Adverse Event Reporting 

When reporting an Adverse Event to the Food and Drug Administration (FDA) the best method is to utilize the FDA Adverse Event Reporting System (FAERS). FAERS is a database that contains adverse event reports, product quality complaints that led to an adverse event, and medication error reports1. All FAERS reports are easily accessible to the public. 
De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.

Ready to learn more about working with us?

Pin It on Pinterest

Share This