GLP vs. GMP

Posted on February 20, 2013

What is Good Laboratory Practice (GLP), and what is Good Manufacturing Practice (GMP)? If you work in the pharmaceutical industry, chances are you have heard these terms before, and have at least a general idea of what they entail: tightly controlled processes, stringent records, focused training, constant analysis, and detailed auditing. Surprisingly, the issues arising from GLP and GMP often stem from a misconception of which quality system standard applies to certain situations. The causes of such confusion can be insufficient scoping activities, misinterpretation of regulatory literature, misguided advice from an outside source, or a sponsor’s demands regarding a particular study.

The confusion surrounding GLP vs. GMP is understandable; after all, since the middle word in GLP is Laboratory, it should apply to anything done in a lab, right? And the same for GMP; Manufacturing practices should only apply to manufacturing lines, right? Unfortunately,...