Good Laboratory Practicequality assuranceDefinitionDefinitionGLPs are the legal requirements delineated by the FDA in 21 CFR Part 58 governing testing laboratories to ensure the quality of nonclinical laboratory studies related to safety ofEncyclopedia of Cancer...
Good Laboratory Practiceor good laboratory practices are accepted methods to carry out activities or operations in a laboratory. The authorities and laboratory organizations say that these practices help ensure safety. They also have a positive influence on the quality of the result. For pharmaceutical ...
2、DefinitionsofTerms术语定义 •2.1GLP:GoodLaboratoryPractice(GLP)isaqualitysystemconcernedwiththeorganizationalprocessandtheconditionsunderwhichnonclinicalhealthandenvironmentalsafetystudiesareplanned,performed,monitored,recorded,archivedandreported.•2.1GLP是一种涉及组织过程和非临床健康和环境安全专题实施条件的质量...
(Section 5) and the practice and documentation of the laboratory. unesdoc.unesco.org 世界反兴奋剂机构的代表将对 ISO 17025 对兴 奋剂控制样品分析的适用(第 5 节)中规定要求的符合情况以及 实验室 的执 行情况 和文件进行审计。 unesdoc.unesco.org [...] appropriate individual (such as the inform...
OECD GLP Principles经济合作与开展组织GLP 原那么Suzhou ResearchLeoLiu西山中科刘振超1INTRODUCTION引言1.1 Purpose目的:To avoid different schemes o
Good Laboratory Practice Regulations 良好实验室规范.pdf,Good Laboratory Practice Regulations Third Edition, Revised and Expanded edited by Sandy Weinberg Muhlenberg College Allentown, Pennsylvania, U.S.A. Marcel Dekker, Inc. New York • Basel Copyright
Good laboratory practice might be used to detect collusion, but it could also serve to protect the researcher from unfounded allegations. In this manner, the application of the basic rules of GLP could be benefit even to a instution or laboratory. 2.1.4 Definition of GLP The quality is the ...
GoodLaboratoryPractices LoriGladney IzabellaOsakwe EndiaFord GLP:GOODLABORATORYPRACTICE GLPisanFDAregulation. Definition:GLPembodiesasetofprinciplesthatprovidesaframeworkwithinwhichlaboratorystudiesareplannedperformed,monitored,reportedandarchived. GLPissometimesconfusedwiththestandardsoflaboratorysafetylikewearingsafetygoggles...
(21 CFR Part 58). GLP applies to nonclinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals) to humans, animals and the environment. An internationally recognized definition of GLP can be found on the website for the Medicines and Healthcare...
9.1General总则9.1.3ThefinalreportshouldbesignedanddatedbytheStudyDirectortoindicateacceptanceofresponsibilityforthevalidityofthedata.TheextentofcompliancewiththesePrinciplesofGoodLaboratoryPracticeshouldbeindicated.9.1.3最终报告一定要得到SD的签署，表示SD愿意对数据有效性负责。最终报告要标明专题遵从GLP原则的程度；...