Results show that less than half of the dose forms could be coded with EDQM standard terms. In addition to that Kappa was found to be moderate, which means rather unconvincing agreement among coders. In conclusion, there is still vast room for improvement in utilization of standardized ...
The reference standard label and the reference standard catalogue (“Unit quantity” heading) declare the total amount of material (active substance and excipients, if any) that has been filled in each vial or ampoule; this information is required by customs authorities. This quantity declared is ...
E2B (R3) 信息中个例安全性报告的剂型和给药途径使用EDQM术语(中文翻译稿)国际人用药品注册技术要求协调会 用户指南 E2B (R3) 信息中个例安全性报告剂型和给药途径的EDQM 术语使用 版本 1.0，2017 年 11 月 16 日
The Blood Guide is elaborated by a dedicated working group of experts nominated by the European Committee on Blood Transfusion (CD-P-TS) to provide state-of-the-art recommendations and guidelines. This new edition introduces major changes in terms of struct...
tificNotes)、标准术语(StandardTerms)、国际 会议学报(ProceedingsofInternationalConfer— ences)、技术指导原则(TechnicalGuides)、批签 发指导原则(BatchReleaseGuidelines)、质量保 证指导原则(QualityAssuranceActivitiesGuide— lines)、输血及器官移植指导原则(BloodTrans- ...
IR SPECTROPHOTOMETERS 201909 ANNEX 4 OF THE OMCL NETWORK GUIDELINE “QUALIFICATION OF EQUIPMENT” QUALIFICATION OF IR SPECTROPHOTOMETERS OMCL 网络指南“仪器确认”附录4 红外光谱仪确认 No te: Manda tory r equir emen ts in this gui deli ne are defined using the terms “sha ll ” or “must ”...
A User Requirements Specification (URS) should describe the functional and technical requirements of the computerised system, as defined by the OMCL, in terms of both software and hardware. It should also cover the aspects of information security and data integrity. 新软件和相关计算机和实验室设备的...
需要金币:*** 金币(10金币=人民币1元) EP标准品的购买方式和价格EDQM.pdf 关闭预览 想预览更多内容,点击免费在线预览全文 免费在线预览全文 内容提供方:118zhuanqian 审核时间:2017-10-24 审核编号:7141006146001052 认证类型:实名认证 能力类型:文档贡献者 ...
-The Ph. Eur. BRP is a secondary standard calibrated in terms of the primary, WHO IS -The process is an arbitrary value assignment rather than a formal metrological calibration -It is costly, and vulnerable -Individual assays are imprecise ...
edqm-计算机系统验证核心文件-2018(中英文)