In the August 24, 2016, Federal Register, FDA proposed amending its regulations for good laboratory practice ("GLP") for nonclinical (often referred to as preclinical) laboratory studies to require a complete quality system approach, referred to as a GLP Quality System, when safety and toxicity studies support or are intended to support applications or submissions for products regulated by FDA. As proposed, the GLP Quality System includes additional responsibilities for testing facility management and new responsibilities for maintaining Standard Operation Procedures ("SOPs"). FDA also proposes revising the definition of "testing facility" to reflect current practices, making it applicable to all nonclinical laboratory studies, regardless of whether they are conducted at a single facility or at multiple sites. It is FDA's expectation that a GLP Quality System will provide the appropriate framework for building quality into a nonclinical laboratory study and will result in more reliable data for FDA to consider when making regulatory decisions. Comments are due November 22, 2016.
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