Jun 18, 2019
Good Laboratory Practice (GLP), are federal regulations that require implementation of a robust quality management system to ensure the validity, integrity and reliability of non-clinical safety data submitted for regulatory evaluation and approval. US Food and Drug Administration (FDA) GLP regulations were first issued by the US in 1978 (1), and, at that time, safety data was mainly obtained from in vivo animal test systems.
Since then, researchers have continued to develop alternative ways to assess drug safety, and now, good laboratory practice regulations can be applied to all non-clinical laboratory safety studies, including in vitro and ex vivo test systems. In short, GLP-compliant studies require documentation (eg standard operating procedures) and are overseen by quality assurance units that perform process-, facility- and study-based inspections.
In this episode, we provide an overview of which studies require Good Laboratory Practice (GLP) compliance, which do not, and why in some cases the choice is unclear.
Original article by Scott Hickman, Dr Brian Ogilvie and Tim Patterson
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