OMCL仪器确认核心文件-中英文

2018-10-31 12:03

Comments / Decisions 建议/决定 Date / Signature: 日期/签名: Date / Signature for approval: 日期/批准签名:

TABLE II

Level II. Installation and release for use 第二级 安装及放行使用

Example of check-list (non-exhaustive) 检查清单举例(未尽列举) Name of instrument and type:

仪器名称和型号 Identification code: 编号

Conformity with order (instrument / material / documentation) 与订单符合性(仪器/材质/文件)

Pass 通过 Fails (description of deficiencies) 未通过(缺陷描述) Check of damages 损伤检查 Pass 通过 Fails (description of deficiencies) 未通过(缺陷描述) Check of required media supply (connections / environmental conditions) 要求环境检查(连接/环境条件) Pass 通过 Fails (description of deficiencies) 未通过(缺陷描述) Installation of instrument(s) including possible control modules 仪器安装,包括可能的控制模块

Pass 通过 Fails (description of deficiencies) 未通过(缺陷描述) Performance of start-up checks and diagnosis functions (1) 开机性能检查和对话功能(1) Pass 通过 Fails (description of deficiencies) 未通过(缺陷描述) (1) If available 如有 Comments 建议 When appropriate, raw data are attached to the instrument documentation 如果可行,原始数据应附于仪器档案。 Date / Signature: 日期/签名: Release and authorisation for use: Date / Signature: 可以放行使用:日期/签名:

Disclaimer: 申明

The present Core Document of the OMCL Guideline ―Qualification of Equipment‖, as well as all its Annexes, have been drafted by ad-hoc working groups of technical experts, mainly coming from Official Medicines Control Laboratories (OMCLs) and only occasionally from other public institutions. These working groups do not include any representative from any commercial organisation.

本指南―仪器确认‖及其附件由技术专家临时工作组起草,这些专家主要来自于OMCL,少数来自其它公共研究所。这些工作组不包括任何来自于商业组织的任何代表。

This Core Document and its Annexes may contain trade names of laboratory instruments, materials and/or reagents. These are exclusively given as example in order to make these guidelines easier to understand and implement, and were found to be suitable when the guideline was being developed. These references do not imply in any way that the mentioned instruments, materials or reagents or their suppliers are especially endorsed, recommended or certified by the EDQM, the OMCL Network or the Council of Europe, in preference to others of a similar nature which are not mentioned. It is therefore acceptable to use instruments, materials and reagents from another source, provided that they fulfil the necessary criteria laid down in these documents and appropriately satisfy the needs of the concerned laboratories in the frame of their specific activities.

本核心文件及其附件可能包括一些化验室仪器、物料和/或试剂的商业名字。在本指南里将这些名称给出作为例子是为了使指南更容易被理解和实施,并且在指南的建立过程中是适用的。这些引用并未暗示所提到的仪器、材料或试剂或其供应商被EDQM,OMCL网络或欧洲委员会特别批准、推荐或认证,并不表示其比其它未提及的类似产品更优良。因此,只要满足在这些文件中设定的必需要标准,满足有关化验室的特别活动要求,使用其它来源的仪器、材料和试剂,是可以接受的。


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