EDQM指南-定量检测项目的复验程序.docx

201410 PA/PH/OMCL (14) 89 结果的评估和报告---附录2A 定量检测项目的复验程序举例(1/2)?? OMCL Network of the Council of Europe QUALITY ASSURANCE DOCUMENT PA/PH/OMCL (14) 89 Evaluation and Reporting of Results 结果的评估和报告 Annex 2A Full document title and reference Evaluation and reporting of Results---Annex 2A Examples of Re-test Programmes for Quantitative Tests PA/PH/OMCL (14) 89 全名和索引 结果的评估和报告---附录2A 定量检测项目的复验程序举例 PA/PH/OMCL(14)89 Document type Guideline 文件类型 指南 Legislative basis / 法规依据 无 Date of first adopt August 2014 首次采纳日期 2014年8月 Date of original entry into force October 2014 首次实施日期 2014年10月 Date of entry into force of revised document / 修订版生效日期 无 Previous titles/other references/last valid version / 之前题目/其它索引号/上一有效版本 无 Custodian Organisation The present document was elaborated by the OMCL Network/EDQM of the Council of Europe 责任机构 现行文件由欧盟委员会EDQM/OMCL网络编制 Concerned Network GEON 相关网络 GEON ? ANNEX II A OF THE OMCL NETWORK GUIDELINE “EVALUATION AND REPORTING OF RESULTS” EXAMPLES OF RE-TEST PROGRAMMES FOR QUANTITATIVE TESTS TABLE OF CONTENT HYPERLINK /blog/getBlog.do?fromString=blogmodule \l _Toc422125257 \t _blank INTRODUCTION 概述 HYPERLINK /blog/getBlog.do?fromString=blogmodule \l _Toc422125258 \t _blank Approach 1: Active pharmaceutical ingredient, 2 initial determinations HYPERLINK /blog/getBlog.do?fromString=blogmodule \l _Toc422125259 \t _blank 方法1：原料药，2次初始检测 HYPERLINK /blog/getBlog.do?fromString=blogmodule \l _Toc422125260 \t _blank Approach 2: Active pharmaceutical ingredient, 3 initial determinations HYPERLINK /blog/getBlog.do?fromString=blogmodule \l _Toc422125261 \t _blank 方法2：原料药，3次原始检测 HYPERLINK /blog/getBlog.do?fromString=blogmodule \l _Toc422125262 \t _blank Approach 3: Impurity tests (e.g. Related substances by HPLC) HYPERLINK /blog/getBlog.do?fromString=blogmodule \l _Toc422125263 \t _blank 方法3：杂质检测 （例如HPLC检测有关物质） HYPERLINK /blog/getBlog.do?fromString=blogmodule \l _Toc422125264 \t _blank Approach 4: Finished products HYPERLINK /blog/getBlog.do?fromString=blog