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GLP & GMP Guide

Testing performed on U.S. Food and Drug Administration (FDA)-regulated products may be performed under different regulations, including Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) and Quality System Regulations (QSR).

This guide outlines the differences between the GLP, pharmaceutical GMP lot release, medical device QSR GMP lot release and GMP in-process testing regulations to help identify when these regulations are applicable.