向客户证明自己的资质和能力 ——适应市场不断提出的新要求 实验室结果得到国际承认的需要 亚太地区实验室认可合作组织 International Laboratory Accreditation Cooperation CNAL IAF19 各国家或地区的认可机构 I L A C APLAC EA IAAC SADCA ILAC/MRA ILAC/MRA 澳大利亚 NATA INMETRO 巴西 SCC加拿大 CNAL HKAS FINAS...
HowDoWeEstablishaLaboratoryControlSystemtoMeetCGMPRegulation?我们应该怎样建立实验室的控制系统以此来满足CGMP规则 STANDRDOPERATIONPROCEDUR(SOP)实验室标准操作程序 GlobalSOPs全球SOPs-Instrument,Methodvalidation,Reagents仪器，方法验证，和试剂-Laboratorynotebook,Documentation,etc.实验手册，文档等等 LocalSOPs国内...
WhatisQualityControl? •Processorsystemformonitoringthequality oflaboratorytesting,andtheaccuracyand precisionofresults •Routinelycollectandanalyzedatafromevery testrunorprocedure •Allowsforimmediatecorrectiveaction •Processorsystemformonitoringthequality oflaboratorytesting,andtheaccuracyand precisionofresults ...
15、 Assurance for Commercially Prepared Microbiological Culture Media -Second Edition; Approved Standard WS 232:2002 WS 232:2002 商业性微生商业性微生物培育基质量检验规程物培育基质量检验规程ISO/TS 11133-1 General guidelines on quality assurance for the preparation of culture media in the laboratory IS...
1983.2. NCCLS C24-A Internal Quality Control Testing : Principles and Definit 15、ions; Approved Guideline. 1991.3. Proposed Guidelines for the Internal quality Control of Analytical Results in the Medical Laboratory, Discussion paper from the members of the External Quality Assessment(EQA) Working ...
in context(从整体上看结果) Do they agree with in-house QC data 是否与室内质量控制数据一致 Trend analysis (consider how sigma is determined) 趋势分析(考虑σ是如何确定的) Performance of other participants 其它参加者的表现 Laboratory Interpretation 实验室的解释 Compare methodology and re-calculate if...
•一、基本概念：•质量管理（Qualitymanagement）：确定质量 方针和质量目标，明确质量职责。通过质量策划---质量控制（对内）---质量保证（对外）和质量改进，实现既定的质量方针和质量目标。ISO9000:2008(3.2.8):质量管理是指在质量方面指挥和控制组织的协调活动 5 第一节概述 •质量控制（Qualitycontrol）...
Quality control data are reviewed and assessed at least monthly by the laboratory director or designee.实验室主任或主任授权人应至少每月审核和评估质控数据。Evidence of Compliance: 质控审核记录,包括失控点、趋势分析或遗漏情况QM/QC(Controls for Nonwaived Tests )CAP URINALYSIS CHECKLIST编码内容 Phase I...
品质专业术语WilliamWang2006414One品质人员名称类QCqualitycontrol品质管理FQCfinalqualitycontrol最终品质管制IPQCinprocessquality
Injection of a deadly dose of anthrax bacilli into a laboratory animal was rendered harmless if common bacteria were injected at the same time. 译文: Pastur和Joubert 指出炭疽杆菌如果与某种常见的细菌共同生长的话就会被杀死。如果这种细菌与致死量的炭疽杆菌同时注射进入受试动物体内,结果表明是无害的。