In some cases, it is impractical to implement a full GLP (US EPA Good Laboratory Practice Regulations, 40 CFR part 160) compliant infrastructure in a facility that conducts mainly non-GLP studies. This is typically the case when specialized equipment or processes are being utilized. Although such facilities can be at the top of their field in specialized procedures, they may have never been introduced to the concept of GLPs so would likely not have processes in place for documented training, written standard operating procedures, formal instrument calibration with documented maintenance, assuring study reconstruction, and/or quality assurance review of data generated and final report. This presentation will discuss the critical aspects required to help assure data integrity, accuracy, and study reconstruction when conducting non-GLP studies.

Non-GLP studies: Critical aspects required to help assure data integrity, accuracy, and study reconstruction

246th National Meeting (2013)

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