When it comes to laboratory testing, there are two terms that are commonly used: a GMP and GLP testing lab. It’s understandable to get these two types of laboratory testing confused. After all, Good Laboratory Practice (GLP) regulations and Good Manufacturing Practice (GMP) regulations both relate to laboratory testing. However, GMP and GLP testing labs are very different.
To give you a better idea of the differences between these two key testing labs, let’s take a closer look at what GMP and GLP testing labs do.
What are GLPs and GMPs designed to do?
GLP testing labs are designed to protect the integrity of scientific data. They provide the FDA and EPA with an auditable and clear record of research studies that are open-ended. Efficacy testing and safety testing ought to be conducted under GLP lab testing regulations.
GMP quality control is designed to demonstrate to the FDA whether or not regulated products are being manufactured according to established manufacturing criteria. The testing of finished pharmaceuticals and other regulated products that are produced for sale ought to be done under GMP lab testing.
One area that isn’t so black and white between GLP and GMP is whether validation studies ought to be done under GMP or GLP. In some cases, validation studies are better done under GLP than GMP. However, it ultimately depends on what is being validated in the study.
Quality Assurance Unit vs. Quality Control Unit
Another key difference between GLP and GMP lab testing is the use of a Quality Assurance Unit or Quality Control Unit. The Quality Assurance Unit in GLP lab testing provides oversight functions only.
The unit inspects the lab for compliance with GLPs. For instance, a lab fume hood needs to be inspected at least once a year. The Quality Assurance Unit also inspects the critical phases of each study. When inspections are finished, the unit informs Testing Facility Management of the integrity of the studies.
In GMP lab testing, there’s a Quality Control Unit. This unit has the authority and responsibility to either approve or reject any and all procedures in manufacturing and testing. The Quality Control Unit is an overall quality system to ensure compliance with GMPs.
Whether you need GLP lab testing or GMP lab testing, Moravek has got you covered with GMP quality assurance and GMP storage conditions. For more information about GLP and GMP lab testing and regulation compliance, contact Moravek today.