Good research practices: a commonsense approach to ensuring quality in research facilities.
This guideline can be a useful tool for assisting and assessing "non-GLP" laboratories in academic and contract settings. This guideline has proven useful in assessing academic and/or contract labs where a final product is needed which would meet FDA expectations for preclinical or clinical research. Because of differing research settings and study types, we apply the standards in a flexible manner. For example, in some settings, the study plan is simply documented in a research notebook as the study unfolds, whereas in other settings a written protocol (which is signed by the principal investigator) is in place prior to study initiation. Additionally, all criteria may not be applicable to every research facility. The focus of this guideline is to ensure that sufficient documentation exists which will allow for study reconstruction and to provide adequate evidence that the raw data generated by the facility are accurate. This guideline is a useful tool for Quality Assurance personnel and can also be used by research personnel in the development of appropriate quality systems for their research environment.
Herman
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Eli Lilly and Company, Quality Assurance (Toxicology), Greenfield, Indiana 46140, USA.
Usher
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RW
D001681:Biological Assay / Q000592:standards; D004282:Documentation / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards; D005160:Facility Design and Construction / Q000592:standards; D017408:Guidelines as Topic; D007753:Laboratories / Q000592:standards*; D007756:Laboratory Animal Science / Q000592:standards; D008331:Management Information Systems / Q000592:standards; D010559:Personnel Management / Q000592:standards; D011785:Quality Assurance, Health Care / Q000592:standards*; D013048:Specimen Handling; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards