Quality Assurance Journal最新文献

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The European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4) 欧洲共同体临床化学和检验医学联合会(EC4)
Quality Assurance Journal Pub Date : 2005-09-01 DOI: 10.1002/QAJ.342
M. Hallworth
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引用次数: 1
A journey along the 21 CFR Part 11 Life Cycle 沿着21 CFR第11部分生命周期的旅程
Quality Assurance Journal Pub Date : 2005-09-01 DOI: 10.1002/QAJ.337
Richard M. Siconolfi
{"title":"A journey along the 21 CFR Part 11 Life Cycle","authors":"Richard M. Siconolfi","doi":"10.1002/QAJ.337","DOIUrl":"https://doi.org/10.1002/QAJ.337","url":null,"abstract":"The Food and Drug Administration's (FDA) Guidance to Industry on 21 Code of Federal Regulations (CFR) Part 11 attempts to explain how industry can develop work processes that allow flexibility with this regulation without compromising compliance. However, to take advantage of this flexibility, our company needed to clearly understand the impact this guidance could have on our current work processes. We focused our attention on two specific areas: (1) developing and deploying a risk assessment and management process, and (2) revising our Part 11 Life Cycle for computerized systems. Copyright © 2005 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"67 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2005-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132778503","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
Effective and practical risk management options for computerised system validation 计算机化系统验证的有效和实用的风险管理方案
Quality Assurance Journal Pub Date : 2005-09-01 DOI: 10.1002/QAJ.339
R. Mcdowall
{"title":"Effective and practical risk management options for computerised system validation","authors":"R. Mcdowall","doi":"10.1002/QAJ.339","DOIUrl":"https://doi.org/10.1002/QAJ.339","url":null,"abstract":"Risk management and risk assessment for computerised systems validation is a key regulatory issue following the Food and Drug Administration's (FDA) reassessment of the 21 Code of Federal Regulation (CFR) Part 11 regulations (Electronic Records and Electronic Signatures final rule). This paper reviews the GXP (i.e. Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP)) regulatory requirements and associated guidance documents and then focuses on the International Standards Organisation (ISO) 14971 risk management process and vocabulary for an overall risk management framework. \u0000 \u0000 \u0000 \u0000Several risk analysis methodologies are presented and assessed for their applicability for computerised system validation (CSV). The conclusion is that one methodology does not fit all situations and the prudent professional should select the best methodology applicable for the problem at hand. Finally, an overall risk management process flow for CSV is presented and discussed based on two questions: ‘Do I need to validate the system?’ and if so, ‘How much work do I need to do?’ A single integrated document is presented as an alternative to a full V-model for the validation of lower risk computer systems. Copyright © 2005 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"48 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2005-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125222309","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: 32
Management tools for the evaluation of compliance and costs in the production of chemical–pharmaceutical companies 用于评估化学制药公司生产中的合规性和成本的管理工具
Quality Assurance Journal Pub Date : 2005-09-01 DOI: 10.1002/QAJ.336
F. Rank, W. Steven, H. Scheuermann, T. Wozniewski, R. Müller
{"title":"Management tools for the evaluation of compliance and costs in the production of chemical–pharmaceutical companies","authors":"F. Rank, W. Steven, H. Scheuermann, T. Wozniewski, R. Müller","doi":"10.1002/QAJ.336","DOIUrl":"https://doi.org/10.1002/QAJ.336","url":null,"abstract":"Due to the stringent and increasingly demanding Good Manufacturing Practice (GMP) and customer requirements, companies within the chemical–pharmaceutical sector share the enormous challenge of evaluating and measuring compliance and costs. The need for implementing a compliance measuring tool for production was identified within the Schering AG and activities were undertaken. The established compliance evaluation system and the first model for a compliance cost system proved to be well-structured and suitable for the production. Consequently, the systems can be adapted by other areas and chemical–pharmaceutical companies and may even be expanded to other areas, such as Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). Copyright © 2005 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"16 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2005-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122948247","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
Establishment of a GLP compliance program for drug safety studies at SIMM 为SIMM的药物安全性研究建立GLP合规计划
Quality Assurance Journal Pub Date : 2005-09-01 DOI: 10.1002/QAJ.338
Xiang-hong Li, Jin Ren
{"title":"Establishment of a GLP compliance program for drug safety studies at SIMM","authors":"Xiang-hong Li, Jin Ren","doi":"10.1002/QAJ.338","DOIUrl":"https://doi.org/10.1002/QAJ.338","url":null,"abstract":"The document ‘Good Laboratory Practice Regulations for Nonclinical Drug Safety Studies’ issued in China on 14 October 1999 was updated by China's State Food and Drug Administration (SFDA) and became effective as of 1 September 2003. In October 2003, SFDA started to commission Good Laboratory Practice (GLP) inspections. Since then, China has adopted a national GLP conformity accreditation system, and it became increasingly required that drug safety studies in China were to be carried out in accordance with the principles of GLP regulations. Development of a standardized safety study platform also plays an important role in the strategy ‘Establishing National Drug Innovation System in Knowledge Innovation’, led by Shanghai Institute of Materia Medica (SIMM), China Academy of Sciences. Demands from outside and inside SIMM required that a GLP compliance program for drug safety studies be established at SIMM. However, the establishment of a GLP compliance program was challenging. In this article, the strategies adopted and the progress made towards meeting the challenges of establishing a GLP compliance program for drug safety studies at SIMM are described. Copyright © 2005 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"28 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2005-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115468054","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
Association of Clinical Research Professionals (ACRP) 临床研究专业人员协会
Quality Assurance Journal Pub Date : 2005-06-01 DOI: 10.1002/QAJ.327
S. Gilkey
{"title":"Association of Clinical Research Professionals (ACRP)","authors":"S. Gilkey","doi":"10.1002/QAJ.327","DOIUrl":"https://doi.org/10.1002/QAJ.327","url":null,"abstract":"","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"141 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2005-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115111237","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: 24
State-by-state clinical trial requirements reference guide, JC Serio, JB Tichner Jr and MH Dilley, Barnett International, Waltham, PA, USA, September 2004, 181 p., USD 24.95, ISBN 1-882615-71-9 各州临床试验要求参考指南,JC Serio, JB Tichner Jr和MH Dilley, Barnett International, Waltham, PA, USA, September 2004, 181页,24.95美元,ISBN 1-882615-71-9
Quality Assurance Journal Pub Date : 2005-06-01 DOI: 10.1002/qaj.323
P. Penney
{"title":"State-by-state clinical trial requirements reference guide, JC Serio, JB Tichner Jr and MH Dilley, Barnett International, Waltham, PA, USA, September 2004, 181 p., USD 24.95, ISBN 1-882615-71-9","authors":"P. Penney","doi":"10.1002/qaj.323","DOIUrl":"https://doi.org/10.1002/qaj.323","url":null,"abstract":"","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"127 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2005-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127073991","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
Federation of European laboratory animal science associations (FELASA) 欧洲实验动物科学协会联合会
Quality Assurance Journal Pub Date : 2005-06-01 DOI: 10.1002/QAJ.324
J. Guillen
{"title":"Federation of European laboratory animal science associations (FELASA)","authors":"J. Guillen","doi":"10.1002/QAJ.324","DOIUrl":"https://doi.org/10.1002/QAJ.324","url":null,"abstract":"","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"28 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2005-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122332825","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: 28
Checklist for GCP compliance investigation (Medical institution) GCP合规性调查核对表(医疗机构)
Quality Assurance Journal Pub Date : 2005-06-01 DOI: 10.1002/QAJ.333
Kiyomi Hirayama, Naohisa Fukuda, H. Satoh, Katsumi Itoh, Kiyoshi Chiba, Yutaka Nakae, Masayuki Takezawa, K. Gotoh
{"title":"Checklist for GCP compliance investigation (Medical institution)","authors":"Kiyomi Hirayama, Naohisa Fukuda, H. Satoh, Katsumi Itoh, Kiyoshi Chiba, Yutaka Nakae, Masayuki Takezawa, K. Gotoh","doi":"10.1002/QAJ.333","DOIUrl":"https://doi.org/10.1002/QAJ.333","url":null,"abstract":"This checklist is an English translation of the Good Clinical Practice (GCP) compliance checklist prepared by the Japanese agency for on-site inspections of medical institutions. Please note that the checklist was translated by the authors and has not received official review by any Japanese agency including the Organization for Pharmaceutical Safety and Research (OPSR). \u0000 \u0000This checklist is an addendum to a previously published article on the evaluation of overseas GCP inspections by the Japanese Regulatory Agency [1]. Copyright © 2005 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"29 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2005-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130119795","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
Who said training in computerized systems validation is boring 谁说计算机系统验证的培训很无聊
Quality Assurance Journal Pub Date : 2005-06-01 DOI: 10.1002/QAJ.326
Marc Brooks, Kjeld Wetlesen
{"title":"Who said training in computerized systems validation is boring","authors":"Marc Brooks, Kjeld Wetlesen","doi":"10.1002/QAJ.326","DOIUrl":"https://doi.org/10.1002/QAJ.326","url":null,"abstract":"This case study describes how ALTANA Pharma provides modular and role-based training in computerized systems validation. The training is fun while providing all necessary information with hands-on experience. This is achieved by using many different kinds of exercises to support the learning experience of the presentations in a creative way. Copyright © 2005 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"14 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2005-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129724004","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
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