Number 23 Advisory Document of the Working Party on Good Laboratory Practice on Quality Assurance and GLP No.23 GLP工作组共识性文件 质量保证与GLP 前言 该版本在2022年07月18日公开发布,是OECD GLP的No.23文件,替代了原来的No.4文件。 该版发布的文件有两个的比较重要的特点,一个是引入了“基于风险(...
4. Quality Assurance and GLP5. Compliance of LaboratorySuppliers6. Application of GLP to FieldStudies7. Application of GLP to Short-termStudies8. Role/Responsibility of StudyDirector9. Guidance for Preparation ofInspection Reports10. Application of GLP to Computer Studies11. Role/Responsibility of ...
OECD非临床质量管理规范 Unclassified ENV/MC/CHEM(98)17Organisation de Coopération et de Développement Economiques OLIS :21-Jan-1998Organisation for Economic Co-operation and Development Dist. :26-Jan-1998___Or. Eng.ENVIRONMENT DIRECTORATE CHEMICALS GROUP AND MANAGEMENT COMMITTEE OECD SERIES ON ...
Self-inspection and/or internal audits are provided by the GMP quality assurance system, therefore, the overall concept is seen as comparable to the one of GMP. The external inspection services document the compliance with the regulation by the GMP-Certificate. The compli...
当局无记录义务不合格机构的撤销有详细的此项归定没有提及TF: test fac ilities TFM: test facilities management MA: monitoring authoritiesRA: regulatory authorities QA: quality assurance SD: study director总体来说,美国对GLP的管理理念与国际上其他机构的不同。如只要自己声明是按照FDA-GLP要求进行的非临床实...
RA: regulatory authoritiesQA: quality assuranceSD: study director 总体来说,美国对GLP的管理理念与国际上其他机构的不同。如只要自己声明是按照FDA-GLP要求进行的非临床实验,从任何一个非临床研究中心出来的数据都可以递交到美国FDA,但都必须随时准备接受美国FD A的现场检查。US-GLP有更多的要求,如在动物关爱方面...
In 2014, OECD issued guidance No.16, guidance on the GLP requirements for peer review of histopathology. The stated purpose of the guidance document is to provide guidance to pathologists, test facility management, study directors and quality assurance personnel on how the peer review of ...
报告9.3Dates日期9.3.1Experimentalstartingandcompletiondates.9.3.1试验开始和结束日期。 9.ReportingofStudyResults 报告9.4Statement日期9.4.1AQualityAssuranceProgrammestatementlistingthetypesofinspectionsmadeandtheirdates,includingthephase(s)inspected,andthedatesanyinspectionresultswerereportedtomanagementandtotheStudyDirec...
9.3Dates日期9.3.1Experimentalstartingandcompletiondates.9.3.1试验开始和结束日期。9.ReportingofStudyResults报告 9.4Statement日期9.4.1AQualityAssuranceProgrammestatementlistingthetypesofinspectionsmadeandtheirdates,includingthephase(s)inspected,andthedatesanyinspectionresultswerereportedtomanagementandtotheStudy...
OECD - Advisory Document of the Working Party on Good Laboratory Practice on Quality Assurance and GLP 30th August 2022 OECD - July 2022 Advisory Document of the Working Party on Good Laboratory Practice on Quality Assurance and GLP Read Here Back to News Archive Share Share your experience on ...