GCLP标准执行指导

Guidelines on Good Clinical Laboratory Practice Bridging Operations between Research and Clinical Research Laboratories J. Ezzellea,, I. R. Rodriguez-Chavezc,, J. M. Dardenb,, M. Stirewalta,, N. Kunwarb, R. Hitchcocka, T. Waltera, and M. P. DJSouzac,* QlPPD, Inc., 929 North Front Street, Wilmington, NC 28401-3331 bHenry M. Jackson Foundation for the Advancement of Military Medicine, 1401 Rockville Pike, Suite 600, Rockville, MD 20852 eDivision of AIDS/National Institutes of Health, 6700b Rockledge Drive, Bethesda, MD, 20817 Abstract A set of Good Clinical Laboratory Practice GCLP standards that embraces both the research and clinical aspects of GLP were developed utilizing a variety of collected regulatory and guidance material. We describe eleven core elements that constitute the GCLP standards with the objective of filling a gap for laboratory guidance, based on IND sponsor requirements, for conducting laboratory testing using specimens from human clinical trials. These GCLP standards provide guidance on implementing GLP requirements that are critical for laboratory operations, such as perance of protocol-mandated safety assays, peripheral blood mononuclear cell processing and immunological or endpoint assays from biological interventions on IND-registered clinical trials. The expectation is that compliance with the GCLP standards, monitored annually by external audits, will allow research and development laboratories to maintain data integrity and to provide immunogenicity, safety, and product efficacy data that is repeatable, reliable, auditable and that can be easily reconstructed in a research setting. Keywords Good Clinical Laboratory Practice Standards; GCLP; Quality Control; Verification; Review 1 Introduction The Good Clinical Laboratory Practices GCLP concept possesses a unique quality, as it embraces both the research and the clinical aspects of GLP. The development of GCLP standards encompasses applicable portions of 21 CFR parts 58 GLP [1] and 42 CFR part 493 Clinical Laboratory Improvement Amendments -CLIA [2], Due to the ambiguity of some parts of the CFR regulations, the GCLP standards are described by merging guidance from regulatory authorities as well as other organizations and accrediting bodies, such as the College of American Pathologists CAP, and the International Organization for Standardization 15189 ISO [3]. The British Association of Research Quality Assurance BARQA took a similar approach by combining Good Clinical Practice GCP and GLP in 2003 [4], Corresponding author E-mail pdsouzaniaid.nih.gov. Phone number 301 496-8379. Fax number 301 402-3684 These authors are equal contributors. Publishers Disclaimer This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before