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
