ABSTRACT
The good laboratory practices (GLP) predate widespread reliance on automated laboratory systems. While the FDA’s Part 11 regulations (see Chap. 3) provide additional guidance in part, the U.S. Environmental Protection Agency (EPA) has taken the GLPs a step further. The EPA has authored and released its own good automated laboratory practices (GALPs), providing detailed guidelines for all automated situations. While the GALPs refer specifically to EPA contract labs, they also provide important recommendations for consideration by managers of all regulated laboratories, including FDA GLP labs.
