对于要出海欧盟的药品项目需要注意了。我们看一下欧盟对于实验室的HPLC的PQ的要求吧，看看和你现在做的有什么不一样的地方吧。
提供者要预先检查并证明由CombiStats所执行的计算是恰当和正确的(主要通过与D.J.Finney所著书籍中发布的数据进行对比,该书是生物分析统计的标准参考书),因此可认为该计算机化系统符合其目的(即满足用户需求)。但是,OMCL必须在从EDQM官网下载之后就确认CombiStats在...
EDQM OMCL质量管理文件:玻璃量具管理(英文原版)-202206 下载积分: 1000 内容提示: N.B. This OMCL Quality Management System document is applicable to members of the European OMCL Network only. Other laboratories might use the document on a voluntary basis. However, please note that the EDQM cannot...
PA-PH-OMCL (16) 89 R2 Management of Samples-2020.08.15-CN&EN.docx PA-PH-OMCL (16) 86 R6 Management of Environmental Conditions-2021.01.01.pdf PA-PH-OMCL (16) 86 R6 Management of Environmental Conditions-2021.01.01-CN&EN.docx PA-PH-OMCL (16) 17 R1 Qualification of Equipment Annex 2...
PA/PH/OMCL (11) 157 5R references / last valid version 原文件名/其它索引号 最后采纳版本: PA/PH/OMCL (11) 157 5R Custodian The present document was elaborated by the OMCL Network / Organisation EDQM of the Council of Europe 托管机构 本文件由欧洲委员会OMCL 网络/EDQM 起草制订 Concerned Netw...
N.B. This OMCL Quality Management System document is applicable to members of the European OMCL Network only. Other laboratories might use the document on a voluntary basis. However, please note that the EDQM cannot treat any questions related to the application of the documents submitted by labo...
OMCL应将结果及其评价誊写为书面报告,交给药监机构,适用性,抄送给其它OMCL和EDQM。检测报告中的信息应基于ISO 17025(第5.10章)的要求,应包括药监当局所要求的信息,以及检测结果的必要说明。报告应指明所采用的检测方法(自建、药典、参考文献)。结果和相应的质量标准应报告为重复检测的结果平均值(根据检测数据的个数),...
1. SCOPE范围This guideline defines basic principles for evaluation and reporting of results of OMCL testing of industrially manufactured medicinal products[1]. The purpose of this OMCL testing is to determine compliance of the product with the specifications laid down in the Marketing Authorisation ...
CustodianOrganisation 管理机构 ThepresentdocumentwaselaboratedbytheOMCLNetwork/EDQMoftheCouncilofEurope ConcernedNetwork相关网络 GEON REPORTINGOFRESULTS结果的报告 GUIDELINEFOROMCLsOMCL指南 1.SCOPE范围 ThisguidelinedefinesbasicprinciplesforevaluationandreportingofresultsofOMCLtestingofindustriallymanufacturedmedicinalproducts...
自2018年7月初开始,OMCL参与了调查和行动解决缬沙坦中检出NDMA事件。该网络同时开发了基于不同的分析原理的缬沙坦中亚硝胺物特定方法。 Three of these methods - established by the Irish OMCL inthe Public Analyst’s Laboratory in Galway (PALG), by the French OMCL at the ANSM site in Montpellier and...