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GLP-compliant assay validation studies: considerations for implementation of regulations and audit of studies 符合glp的测定验证研究:法规实施和研究审计的考虑
Quality Assurance Journal Pub Date : 2006-06-01 DOI: 10.1002/QAJ.365
Henry Li, G. Sharp, C. Pilkington, D. Pifat, S. Petteway
{"title":"GLP-compliant assay validation studies: considerations for implementation of regulations and audit of studies","authors":"Henry Li, G. Sharp, C. Pilkington, D. Pifat, S. Petteway","doi":"10.1002/QAJ.365","DOIUrl":"https://doi.org/10.1002/QAJ.365","url":null,"abstract":"Bioanalytical methods used in nonclinical safety studies are validated to demonstrate that the methods are reliable and reproducible for the intended use. Analytical method validation studies should be designed according to regulatory guidance on method validation. A cell-based assay is described to discuss fundamental validation parameters, such as repeatability, immediate precision, accuracy, and linearity. A Good Laboratory Practice (GLP) compliance program provides a useful platform for ensuring data integrity in assay validation studies. A good understanding of the method validation concepts and regulatory requirements will help Quality Assurance Unit (QAU) auditors focus on key areas and be more effective when auditing assay validation protocols, final reports, and associated data. Copyright © 2006 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"42 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2006-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114568822","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 5
Ms in Clinical Research Organization and Management - Drexel University College of Medicine 德雷塞尔大学医学院临床研究组织与管理硕士
Quality Assurance Journal Pub Date : 2006-06-01 DOI: 10.1002/QAJ.366
W. Hirschhorn, Drexel eLearning
{"title":"Ms in Clinical Research Organization and Management - Drexel University College of Medicine","authors":"W. Hirschhorn, Drexel eLearning","doi":"10.1002/QAJ.366","DOIUrl":"https://doi.org/10.1002/QAJ.366","url":null,"abstract":"","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"2380 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2006-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132215192","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Utah Medical Products Inc. and the FDA: Regulatory Dogma versus Flexible Interpretation 犹他医疗产品公司和FDA:监管教条与灵活解释
Quality Assurance Journal Pub Date : 2006-06-01 DOI: 10.1002/QAJ.371
C. Burgess, R. Mcdowall
{"title":"Utah Medical Products Inc. and the FDA: Regulatory Dogma versus Flexible Interpretation","authors":"C. Burgess, R. Mcdowall","doi":"10.1002/QAJ.371","DOIUrl":"https://doi.org/10.1002/QAJ.371","url":null,"abstract":"This paper reviews the regulatory compliance background and the 2005 court case between the Food and Drug Administration (FDA) and Utah Medical Products Incorporated which supported the company's and not the Agency's interpretation of 21 Code of Federal Regulations (CFR) Part 820, the Quality System Regulations (QSR). This is the first time that the Agency has lost such a court case; the key issues in the case are presented and discussed. The judgement also shows the value of re-reading the regulations to interpret what is actually required rather than custom and practice. Copyright © 2006 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"41 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2006-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133373678","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
International Marketing Applications according to the ICH CTD format: comparison of structure and document requirements 国际市场营销应用根据ICH CTD格式:结构和文件要求的比较
Quality Assurance Journal Pub Date : 2006-06-01 DOI: 10.1002/QAJ.374
R. Gelman
{"title":"International Marketing Applications according to the ICH CTD format: comparison of structure and document requirements","authors":"R. Gelman","doi":"10.1002/QAJ.374","DOIUrl":"https://doi.org/10.1002/QAJ.374","url":null,"abstract":"With the development of the Common Technical Document (CTD) by the International Conference on Harmonisation (ICH), United States, European Union and Japan now have a common format for the organization of documents in regulatory applications. This paper presents a top-level assessment of how the required technical contents of the Biologic License Application (BLA), the Marketing Authorization Application (MAA) and Japan's New Drug Application should be structured according to the ICH CTD format. The article may be of assistance for Quality Assurance auditor when auditing MAAs. Copyright © 2006 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2006-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127457175","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
Bioanalytical quality assurance: concepts and concerns 生物分析质量保证:概念和关注点
Quality Assurance Journal Pub Date : 2006-06-01 DOI: 10.1002/QAJ.372
Anthony B. Jones
{"title":"Bioanalytical quality assurance: concepts and concerns","authors":"Anthony B. Jones","doi":"10.1002/QAJ.372","DOIUrl":"https://doi.org/10.1002/QAJ.372","url":null,"abstract":"The BioAnalytical Specialty Section (BASS) of the Society of Quality Assurance is a group of Quality Assurance professionals who have an interest and expertise in assuring the quality of bioanalytical data. This paper presents an overview of the regulatory requirements for bioanalysis and some of the topics that have been discussed by the BASS group. This initial article will be followed by more specific articles that we hope will contribute to better understanding and consistency in the conduct, audit and reporting of bioanalytical studies. Copyright © 2006 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"3 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2006-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130152519","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 7
Special requirements for GLP studies with ‘big’ animals 对“大型”动物GLP研究的特殊要求
Quality Assurance Journal Pub Date : 2006-06-01 DOI: 10.1002/QAJ.368
Norbert Hochheimer
{"title":"Special requirements for GLP studies with ‘big’ animals","authors":"Norbert Hochheimer","doi":"10.1002/QAJ.368","DOIUrl":"https://doi.org/10.1002/QAJ.368","url":null,"abstract":"The article describes the special requirements for Good Laboratory Practice (GLP) studies with farm animals. Typically, GLP studies are conducted with small laboratory animals such as mice, rats and guinea pigs; GLP studies with big animals are rarely performed. This paper highlights the differences in housing and handling for small and big animals and discusses areas specific to GLP studies with farm animals. While the article draws on observations made and regulations applicable in Germany, the information may be useful for assessing GLP studies with large animals in other countries. Copyright © 2006 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"100 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2006-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124124803","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Technology‐driven forms of quality improvement and technical evolution 技术驱动的质量改进和技术演进形式
Quality Assurance Journal Pub Date : 2006-03-01 DOI: 10.1002/QAJ.359
J. Freiesleben
{"title":"Technology‐driven forms of quality improvement and technical evolution","authors":"J. Freiesleben","doi":"10.1002/QAJ.359","DOIUrl":"https://doi.org/10.1002/QAJ.359","url":null,"abstract":"The success and extent of quality improvement efforts is largely influenced by the technological options available to a company. Technology, thereby, not only impacts production quality during problem elimination, but also preceding and following an actual improvement in the form of problem prevention. In the process design stage, the production setup determines to a large degree the severity of potential quality problems, and in the quality maintenance stage, the choice of technology has a large influence on the maintenance of efficiency and effectiveness. This article therefore discusses the paramount role of technology connected to quality improvement. It furthermore focuses on the economic implications of different technological alternatives, as well as on success factors to facilitate the determination of a company's quality strategy. Copyright © 2006 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"4 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2006-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128807034","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Good Laboratory Practice (GLP) ‐ guidelines for the acquisition and processing of electronic raw data in a GLP environment 良好实验室规范(GLP)—在GLP环境中获取和处理电子原始数据的指南
Quality Assurance Journal Pub Date : 2006-03-01 DOI: 10.1002/QAJ.356
S. Hassler, G. Donzé, Peter M. Esch, Bruno Eschbach, Hans Hartmann, Leo Hutter, U. Timm, H. Saxer
{"title":"Good Laboratory Practice (GLP) ‐ guidelines for the acquisition and processing of electronic raw data in a GLP environment","authors":"S. Hassler, G. Donzé, Peter M. Esch, Bruno Eschbach, Hans Hartmann, Leo Hutter, U. Timm, H. Saxer","doi":"10.1002/QAJ.356","DOIUrl":"https://doi.org/10.1002/QAJ.356","url":null,"abstract":"The aim of the present document is to provide guidance on the Good Laboratory Practice (GLP)-compliant acquisition and processing of electronic raw data. The life cycle of electronic raw data and their related meta data from the data acquisition to the data processing and the generation of results is shown. The different roles and responsibilities for data entry, data editing, data approval, and data freezing are specified. The requirements for time stamps, audit trails, and the identification of acting persons are described. Furthermore different levels of laboratory instrument integration in a LIMS are discussed. \u0000 \u0000This document is intended to aid test facilities, and to promote the use of a common standard, but it should not be considered as a legally binding document. These guidelines may evolve with experience over the next few years and may be modified to reflect interpretations made by other Organisation for Economic Co-operation and Development (OECD) member countries. The present guidelines were prepared by the Working Group on Information Technology (Arbeitsgruppe Informationstechnologie, AGIT). This group consists of representatives from Swiss industry and the Swiss GLP monitoring authorities. Copyright © 2006 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"24 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2006-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124313149","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 5
Experience with the implementation of the EU Clinical Trials Directive - first results of a survey initiated by the BVMA e.V. 实施欧盟临床试验指令的经验——由BVMA e.V发起的一项调查的初步结果。
Quality Assurance Journal Pub Date : 2006-03-01 DOI: 10.1002/QAJ.358
M. Gierend, Dagmar Chase, W. Feuerer
{"title":"Experience with the implementation of the EU Clinical Trials Directive - first results of a survey initiated by the BVMA e.V.","authors":"M. Gierend, Dagmar Chase, W. Feuerer","doi":"10.1002/QAJ.358","DOIUrl":"https://doi.org/10.1002/QAJ.358","url":null,"abstract":"By 1 May 2004, all European Union (EU) member states had to implement the EU Clinical Trials Directive 2001/20/EC into national legislation to provide the basis for a common clinical trial development procedure throughout the EU. Shortly after this date it became obvious that far from all the member states could keep to the timelines, and even at the end of 2005 some of them still have to do their homework. However, most of the member states have implemented the Directive in the meantime and it was the intention of this survey to collect and compare information about first experience with the new procedures in different countries. Hence, the Board of the German Federal Association of Contract Research Organizations (BVMA e.V.) designed a questionnaire, sent this to all its members, collected the incoming information and evaluated the data obtained. \u0000 \u0000 \u0000 \u0000Up to a total of 337 submissions (to Competent Authorities (CA) and Ethics Committees (EC)), covering most of the EU member states (except Luxembourg, Cyprus and The Netherlands), were evaluated. Our first results revealed that very few CA and EC submissions were finally rejected and the timelines were mainly kept by CA and EC. Formal and content-related deficiency rates varied from 0 to 100% (depending on countries and total number of mentions) but generally were below 50%. The overall experience with CA and EC so far is rated with ‘good’ on average, even if specific peculiarities in some countries still might influence the timelines of the submission procedures and thus the start of studies. Copyright © 2006 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2006-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131278685","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Quality assurance implications for computerized systems following the Able Laboratories FDA Inspection Able 实验室接受 FDA 检查后对计算机化系统质量保证的影响
Quality Assurance Journal Pub Date : 2006-03-01 DOI: 10.1002/QAJ.357
R. Mcdowall
{"title":"Quality assurance implications for computerized systems following the Able Laboratories FDA Inspection","authors":"R. Mcdowall","doi":"10.1002/QAJ.357","DOIUrl":"https://doi.org/10.1002/QAJ.357","url":null,"abstract":"The quality assurance implications for hybrid systems (electronic records with handwritten signatures on the paper copies) following an inspection of a computerized system by the United States Food and Drug Administration (FDA) are explored. The major compliance problem occurred because the paper copies differed, sometime radically, from the electronic records contained within a chromatography data system. These non-compliances ultimately caused the inspected company to go bankrupt. Copyright © 2006 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"90 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2006-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128265189","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
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