欧洲药典45的执行.pptVIP

Translated and prepared by HUKAI 欧洲药品质量指导委员会(EDQM)欧洲药典专论适应性认证 写给相关的人 CEP/RZ/PH/2002/10743 Sb/CP 斯特拉斯堡,2003年2月 主题：欧洲药典增补4.5的执行 Supplement 4.5 of the European Pharmacopoeia describing a number of revised monographs will be implemented 1 July 2003. It is your responsibility as holder of a certificate of suitability to update specifications and test procedures for concerned pharmaceutical substances to implement the new version 07/2003 or any corrected text of the monograph in due time. 含有一些修订过的专论的欧洲药典增补4.5将于2003年7月开始执行。作为证书持有者，你有责任及时地就相关的原料药更新质量规格和测试程序以执行2003年7月的新版或专论修订过的内容。 You hold a certificate for a substance for which a technically revised monograph has been published (section ‘REVISED TEXTS’, see list enclosed), you should proceed as follows: 如果你持有某一原料药的证书，而其专论已有技术性修改并出版(见所附的‘修订文本’章节)，那么你要进行如下处理： Amendments to the monograph (eg. Preparation of a reference solution, deletion of an identification test,…) that do not require submission on your part of additional documents to complete the Certification file: Substances concerned by such amendments are annotated in the attached list as ‘1’. A reply to this letter is not necessary. 不需要提交补充资料的药典专论修改(如，对照溶液的制备，去除某些鉴别实验…):与这些修改相关的原料药在附表 上标上了‘1’。对于这些，是不需要答复这封信。 Amendments to the monograph that, as laid down in Resolution AP-CSP (99) 4, require updating of the Certification file to demonstrate whether the substance complies with the new requirements of the monograph; the extent of information to be provided depends on the actual changes/modifications in the section ‘Tests’: Updated substance specifications referring to the revised monograph and certificates of batch analyses of 1 or 2 batches based on new instructions may suffice which is annotated in the attached list as ‘2’. 如Resolution AP-CSP(99)4中所规定的，专论的修订需要更新认证文件以说明该原料药是否符合新的专论要求；所要提供资料的程度取决于‘测试’项下的实际变更/修改。涉及到修订后专论的已更新的原料药质量规格和基于新的(检验)规程的1或2批批分析报告单将足以满足列表‘2’中评注的项。 Where further supporting documentation will be necessary to cover any other i