OECD Good laboratory practice (GLP)中英文对照PPT版复习课程.ppt

* 1 * 1 OECD GLP Principles经济合作与发展组织GLP 原则 Suzhou Research-LeoLiu 西山中科-刘振超 9. Reporting of Study Results报告 9.1 General 总则 9.1.3The final report should be signed and dated by the Study Director to indicate acceptance of responsibility for the validity of the data. The extent of compliance with these Principles of Good Laboratory Practice should be indicated. 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； 9. Reporting of Study Results报告 9.1 General 总则 9.1.4Corrections and additions to a final report should be in the form of amendments. Amendments should clearly specify the reason for the corrections or additions and should be signed and dated by the Study Director. 9.1.4对最终报告的修正和补充应当以最终报告变更的形式体现。此变更要清晰的体现所修正和补充的内容及原因，并得到SD的签署。 9. Reporting of Study Results报告 9.1 General 总则 9.1.5Reformatting of the final report to comply with the submission requirements of a national registration or regulatory authority does not constitute a correction, addition or amendment to the final report. 9.1.5为满足注册要求，对最终报告格式的修改不构成对最终报告的变更。 9. Reporting of Study Results报告 9.2 Content of the Final Report最终报告的内容 The final report should include, but not be limited to, the following information: 最终报告应当包含，但不局限于以下信息： 9.2.1 Identification of the Study, the Test Item and Reference Item. 9.2.1专题、供试品和对照品的标识。 9. Reporting of Study Results报告 9.2 Content of the Final Report最终报告的内容 9.2.1a) A descriptive title; 9.2.1a)描述性标题（专题名称）； 9.2.1b) Identification of the test item by code or name (IUPAC, CAS number, biological parameters, etc.); 9.2.1b)供试品的标识（IUPAC、CAS号、生物参数等）； 9. Reporting of Study Results报告 9.2 Content of the Final Report最终报告的内容 9.2.1c) Identification of the reference item by name; 9.2.1c)对照品的标识（通过名称）； 9.2.1d) Characterisation of the test item including purity, stability and homogeneity. 9.2.1d)供试品的属性包括纯度（含量）、稳定性和均一性。 9. Reporting of Study Results报告 9.2 Content of the Final Report最终报告的内容 9.2.2Information Concerning the Sponsor and the Test Facility委托方和试验机构的信息 9.2.2a) Name and address