FDA、EPA和OECD的GLP比较.docx

Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP??Document issued on: June 2004U.S. Department of Health and Human ServicesFood And Drug AdministrationOffice of Regulatory Affairs (ORA)Table of Contents?Preface1Scope and Authority2Definitions3Organization and Personnel 4Facilities 5Equipment6Facility Operation7Articles8Protocol and Conduct9Records and Reports10Disqualification11Preface?Public CommentComments and suggestions may be submitted at any time to the Division of Compliance Policy (HFC-230), Office of Enforcement, Office of Regulatory Affairs (ORA), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Please refer to the exact title of this document when submitting comments or suggestions. For questions regarding the use or interpretation of this chart contact Chris Anders at (240) 632-6853, or e-mail Christopher.Anders@.Additional CopiesAdditional copies are available from the Internet at: ?/ora/compliance_ref/bimo/fda_epa_oecd.html. Submit written requests for single copies of the guidance entitled Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP to the Division of Compliance Policy (HFC-230), Office of Enforcement, Office of Regulatory Affairs (ORA), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist the office in processing your requests.Scope and AuthorityComparison of FDA, EPA, OECD GLPScope and AuthorityTopicFDAEPAOECDScopeSec. 58.1(a) This part prescribes good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products. Compliance with this part is