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GLP SOPs for equipment calibration and maintenance. Part 5: SOP templates and SOP on SOPs 设备校准和维护的GLP标准操作规程。第5部分:SOP模板和SOP上的SOP
Quality Assurance Journal Pub Date : 2007-09-01 DOI: 10.1002/QAJ.427
I. Colligon, M. Rosa
{"title":"GLP SOPs for equipment calibration and maintenance. Part 5: SOP templates and SOP on SOPs","authors":"I. Colligon, M. Rosa","doi":"10.1002/QAJ.427","DOIUrl":"https://doi.org/10.1002/QAJ.427","url":null,"abstract":"Document templates are valuable tools and Standard Operating Procedure (SOP) templates are no exception. The true value of the ‘SOP on SOPs’ is often underestimated. This installment of the series is dedicated to the discussion of the SOP on SOPs and of the SOP templates, their use and ways of making them better. Copyright © 2008 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"23 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2007-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116632613","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
Towards norms for accreditation of biobanks for human health and medical research: compilation of existing guidelines into an ISO certification/accreditation norm‐compatible format 制定用于人类健康和医学研究的生物库认证规范:将现有准则汇编成与ISO认证/认可规范兼容的格式
Quality Assurance Journal Pub Date : 2007-09-01 DOI: 10.1002/QAJ.425
F. Betsou, A. Luzergues, A. Carter, Peter Geary, P. Riegman, B. Clark, M. Morente, J. Vaught, R. Dhirr, C. Druez-Vérité
{"title":"Towards norms for accreditation of biobanks for human health and medical research: compilation of existing guidelines into an ISO certification/accreditation norm‐compatible format","authors":"F. Betsou, A. Luzergues, A. Carter, Peter Geary, P. Riegman, B. Clark, M. Morente, J. Vaught, R. Dhirr, C. Druez-Vérité","doi":"10.1002/QAJ.425","DOIUrl":"https://doi.org/10.1002/QAJ.425","url":null,"abstract":"In recent years, biobanks have evolved into professional infrastructures that acquire, validate, process, store, manage and distribute biological material of human origin to public or private end-users/researchers. This article (a) highlights the importance of quality assurance for both the biobank basic processes and sample annotation in order to ensure reliable results of research based on these samples, (b) suggests that certification according to international standards can contribute to the organization of the biobanking processes while accreditation can contribute to the organization of sample characterization/validation, and (c) provides a compilation of all existing guidelines against an International Organization for Standardization (ISO) format. Copyright © 2008 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"36 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2007-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132916801","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: 41
WHO/TDR quality practices in basic biomedical research (QPBR). A conversation between Nadya Gawadi and David Long 世卫组织/TDR在基础生物医学研究中的质量做法。Nadya Gawadi和David Long的对话
Quality Assurance Journal Pub Date : 2007-09-01 DOI: 10.1002/QAJ.421
N. Gawadi, David Long
{"title":"WHO/TDR quality practices in basic biomedical research (QPBR). A conversation between Nadya Gawadi and David Long","authors":"N. Gawadi, David Long","doi":"10.1002/QAJ.421","DOIUrl":"https://doi.org/10.1002/QAJ.421","url":null,"abstract":"","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"18 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2007-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128765768","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
Better medicines for children: clinical investigation of medicinal products in the paediatric population ‐ a QA perspective 为儿童提供更好的药物:儿科人群中药品的临床调查——QA视角
Quality Assurance Journal Pub Date : 2007-06-01 DOI: 10.1002/QAJ.422
G. Fortwengel, H. Ostermann, R. Staudinger
{"title":"Better medicines for children: clinical investigation of medicinal products in the paediatric population ‐ a QA perspective","authors":"G. Fortwengel, H. Ostermann, R. Staudinger","doi":"10.1002/QAJ.422","DOIUrl":"https://doi.org/10.1002/QAJ.422","url":null,"abstract":"Currently the number of medicinal products labelled for paediatric use is limited. Clinical trials involving children are surely amongst the most challenging types of studies performed from a scientific, ethical and medical perspective. The article provides an outline of critical issues to be considered when developing drugs in this population. Copyright © 2008 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"451 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2007-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131426088","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
A Dog's Life? 狗的生活?
Quality Assurance Journal Pub Date : 2007-06-01 DOI: 10.1002/qaj.413
Anthony B. Jones
{"title":"A Dog's Life?","authors":"Anthony B. Jones","doi":"10.1002/qaj.413","DOIUrl":"https://doi.org/10.1002/qaj.413","url":null,"abstract":"","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"50 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2007-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116450826","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
Current challenges for FDA‐regulated bioanalytical laboratories for human (BA/BE) studies, Part II: recent FDA Inspection trends for bioanalytical laboratories using LC/MS/MS methods and FDA Inspection readiness preparation FDA监管的人(BA/BE)研究生物分析实验室当前面临的挑战，第二部分:使用LC/MS/MS方法和FDA检查准备的生物分析实验室的最新FDA检查趋势
Quality Assurance Journal Pub Date : 2007-06-01 DOI: 10.1002/QAJ.411
Frank Chow, Steven J. K. Lum, A. Ocampo, Paul Vogel
{"title":"Current challenges for FDA‐regulated bioanalytical laboratories for human (BA/BE) studies, Part II: recent FDA Inspection trends for bioanalytical laboratories using LC/MS/MS methods and FDA Inspection readiness preparation","authors":"Frank Chow, Steven J. K. Lum, A. Ocampo, Paul Vogel","doi":"10.1002/QAJ.411","DOIUrl":"https://doi.org/10.1002/QAJ.411","url":null,"abstract":"This article is the second of a three-part series that deals with the recent Food and Drug Administration (FDA) inspectional trends for bioanalytical laboratories performing analysis for human bioavailability (BA)/bioequivalence (BE) studies. While the FDA compliance expectations have been published in various FDA guidances, as well as the Compliance Program Guidance Manual for current Good Manufacturing Practice and Good Laboratory Practice (as discussed in Part 1 of this series), there are no specific regulations that mandate the operation and control of the bioanalytical laboratories conducting analyses for human BA/BE studies. It is apparent that the compliance standards and analytical testing requirements have been subject to a dynamically evolving process, slowly developed through several workshops jointly sponsored by the FDA and the pharmaceutical industry in the past decade. As the FDA expectations in the practices of bioanalytical laboratories become clearer, an increased trend is observed for the number of FDA 483 observations and untitled letters issued. This article provides a detailed analysis of the current FDA guidance and apparent expectations based on inspectional trends observed. In addition, the compliance and scientific basis of these dynamically evolving regulatory issues are also discussed, where applicable. Copyright © 2008 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"37 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2007-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123407388","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: 8
The clinical investigator site audit – process‐driven good clinical practice 临床研究者现场审核过程驱动的良好临床规范
Quality Assurance Journal Pub Date : 2007-06-01 DOI: 10.1002/QAJ.412
T. Winchell
{"title":"The clinical investigator site audit – process‐driven good clinical practice","authors":"T. Winchell","doi":"10.1002/QAJ.412","DOIUrl":"https://doi.org/10.1002/QAJ.412","url":null,"abstract":"This article describes a process-driven approach to the conduct of a Good Clinical Practice (GCP) audit at a clinical investigator site and to the assessment of systemic GCP compliance in just a few days with little or no background information. The technique involves looking at the site and resulting observations from a system-related point of view, with the primary goal of finding flaws in methods of operation as opposed to looking for isolated errors. Then, expanding the impact of corrective actions to the maximum extent (i.e. to all systemic flaws). To put it simply, it is a process-driven approach with the ultimate goal of getting the GCP system under satisfactory control. Copyright © 2008 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"124 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2007-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123344546","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: 3
Developing and implementing a comprehensive clinical QA audit program 制定和实施全面的临床质量保证审核程序
Quality Assurance Journal Pub Date : 2007-06-01 DOI: 10.1002/QAJ.420
Henry Li, Susan Hawlk, Kim Hanna, Gerald L. Klein, S. Petteway
{"title":"Developing and implementing a comprehensive clinical QA audit program","authors":"Henry Li, Susan Hawlk, Kim Hanna, Gerald L. Klein, S. Petteway","doi":"10.1002/QAJ.420","DOIUrl":"https://doi.org/10.1002/QAJ.420","url":null,"abstract":"The Clinical Quality Assurance (CQA) audit program is a key element of a Good Clinical Practice (GCP) quality system. The objective of a CQA audit program is to ensure that trial conduct and data quality meet protocol-specified, GCP, and applicable regulatory requirements. Due to the increasing complexity of clinical trials and regulatory scrutiny, the components of a CQA audit program and the approaches taken towards designing and managing audits are constantly evolving. In this paper, we will focus on the strategies that are used to develop and implement a CQA audit program, including types of audits to be conducted and the quality approaches taken to manage and improve the CQA audit program. Copyright © 2008 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"34 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2007-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131418516","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: 11
Quality assurance in cardiac surgery: setting up the Austrian heart register. Are standard hospital information systems suitable? 心脏外科的质量保证:建立奥地利心脏登记。标准的医院信息系统是否适用?
Quality Assurance Journal Pub Date : 2007-06-01 DOI: 10.1002/QAJ.415
Oskar Staudinger, Bettina Staudinger, H. Ostermann, R. Staudinger, B. Tilg
{"title":"Quality assurance in cardiac surgery: setting up the Austrian heart register. Are standard hospital information systems suitable?","authors":"Oskar Staudinger, Bettina Staudinger, H. Ostermann, R. Staudinger, B. Tilg","doi":"10.1002/QAJ.415","DOIUrl":"https://doi.org/10.1002/QAJ.415","url":null,"abstract":"Objectives: The Austrian Health 2006 Structural Plan of 28 June 2006 requires that reference centres for cardiac surgery ‘participate in result-quality registers (e.g. heart registers)’. The aim of the project was to determine the conditions under which existing hospital information systems (HIS) would be suitable for the intended heart register system. \u0000 \u0000Methods: Between November 2004 and December 2005, a survey was performed in the Austrian heart centers in order to ascertain the medical requirements, the existing technical and organizational situation, and the demands potential users would make on a comprehensive, national heart register. The possibilities of using existing hospital information systems for this purpose were evaluated on the basis of a criteria catalogue. \u0000 \u0000Results: From the medical point of view, the requirements of a heart register covering the whole of Austria, though complex, are readily definable. The reality of heterogeneous information technology (IT) landscapes, coupled with demands for interactivity (on-line queries to a central cardiac database) and benchmarking the users within a single system, combined with what must objectively be regarded as a small group of users, are the reasons why this function is not provided as standard in any HIS. \u0000 \u0000Conclusion: The level of standardization of predictive models and data records is too low in the light of the local and national demands and expectations of a heart register, so that an adequate Quality Assurance (QA) function for cardiac surgeries, which is based on statistical data, is not offered as a standard module in today's HIS. Copyright © 2008 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"408 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2007-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128973110","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
Ethics Committees in India 印度伦理委员会
Quality Assurance Journal Pub Date : 2007-06-01 DOI: 10.1002/QAJ.414
N. Dent, A. Krishan
{"title":"Ethics Committees in India","authors":"N. Dent, A. Krishan","doi":"10.1002/QAJ.414","DOIUrl":"https://doi.org/10.1002/QAJ.414","url":null,"abstract":"This article sets out to give an introduction to the ethics committee situation in India, explores how education and training is being undertaken and explains the governmental requirements for setting up, running and maintaining ethics committees. Copyright © 2008 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"59 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2007-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124007690","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: 3
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