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The JSQA guideline for GCP auditing 用于GCP审计的JSQA指南
Quality Assurance Journal Pub Date : 2007-03-01 DOI: 10.1002/QAJ.403
Hiroshi Shimokai, Seiichi Hata, T. Tamura, Yoshiaki Yano, Shuhei Abe, Masayuki Takezawa, M. Yogo, T. Kajiho, Kuniko Gotou, Akio Izawa, Muneyoshi Ookawa, Hiroyasu Yamashita, Fumiko Alaya, Yukiko Shiromoto, Kiyoshi Takahashi
{"title":"The JSQA guideline for GCP auditing","authors":"Hiroshi Shimokai, Seiichi Hata, T. Tamura, Yoshiaki Yano, Shuhei Abe, Masayuki Takezawa, M. Yogo, T. Kajiho, Kuniko Gotou, Akio Izawa, Muneyoshi Ookawa, Hiroyasu Yamashita, Fumiko Alaya, Yukiko Shiromoto, Kiyoshi Takahashi","doi":"10.1002/QAJ.403","DOIUrl":"https://doi.org/10.1002/QAJ.403","url":null,"abstract":"The International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) has been adopted by three regions USA, Europe and Japan and implemented since 1996. Details of GCP auditing are not provided in ICH GCP. The Japan Society of Quality Assurance (JSQA) has prepared ‘The JSQA GCP Guideline for GCP Auditing’ to promote the global discussion on GCP auditing and expects to establish a global guideline on GCP auditing along with ICH GCP. \u0000 \u0000The guideline will include the mission and the organization of a sponsor's auditing department and establish the principles for planning, performing, and reporting audits. The guideline is expected to be a basic principle along with ICH GCP for not only sponsor's auditors, but also independent auditors and auditors of Contract Research Organizations (CROs) to conduct an audit in the various situations of each country and sponsor. Copyright © 2007 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"43 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2007-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116363832","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
Your contributions are highly valued 你的贡献是非常宝贵的
Quality Assurance Journal Pub Date : 2007-03-01 DOI: 10.1002/QAJ.410
R. Hattemer‐Apostel
{"title":"Your contributions are highly valued","authors":"R. Hattemer‐Apostel","doi":"10.1002/QAJ.410","DOIUrl":"https://doi.org/10.1002/QAJ.410","url":null,"abstract":"","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"8 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2007-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128907842","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
GLP SOPs for equipment calibration and maintenance. Part 4: logistics of SOP writing 设备校准和维护的GLP标准操作规程。第四部分:物流SOP的编写
Quality Assurance Journal Pub Date : 2007-03-01 DOI: 10.1002/QAJ.402
I. Colligon, M. Rosa
{"title":"GLP SOPs for equipment calibration and maintenance. Part 4: logistics of SOP writing","authors":"I. Colligon, M. Rosa","doi":"10.1002/QAJ.402","DOIUrl":"https://doi.org/10.1002/QAJ.402","url":null,"abstract":"On the surface, writing Standard Operating Procedures (SOPs) seems fairly simple. All you need to do is write it all down. Unfortunately as the cliches go, appearances can be deceiving, and if it looks too good to be true, it probably is. This is not to say that the act of getting the processes on paper has to be torturous, it just requires some forethought and planning. \u0000 \u0000 \u0000 \u0000In the previous installments of this series (Qual Assur J 2006; 10(2): 107–110 [1]; Qual Assur J 2006; 10(3): 203–207; Qual Assur J 2006; 10(4): 279–285), we have discussed the preparatory steps for writing SOPs, such as the process inventory (Qual Assur J 2006; 10(3): 203–207) and mapping (Qual Assur J 2006; 10(4): 279–285). In this portion, we are going to discuss the logistics of creating SOPs. Copyright © 2007 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"14 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2007-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121693271","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: 4
Does the MAD system make test facilities mad MAD系统会使测试设备发疯吗
Quality Assurance Journal Pub Date : 2006-12-01 DOI: 10.1002/qaj.389
V. Stanley
{"title":"Does the MAD system make test facilities mad","authors":"V. Stanley","doi":"10.1002/qaj.389","DOIUrl":"https://doi.org/10.1002/qaj.389","url":null,"abstract":"There needs more clarity in ad hoc Good Laboratory Practice (GLP) certification conferred to test facilities of non-member economies. There is a similar kind of issue with the ‘GLP status’ of the test data generated by a test facility that has been conferred GLP certification by the country that is only a provisional adherent. In both cases, the objective of the Mutual Acceptance of Data (MAD) system will not be fulfilled if the answer is ‘no’. Copyright © 2006 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"8 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2006-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121676106","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
Moral decision‐making among professionals in the pharmaceutical industry: a ‘communities of practice’ model 制药行业专业人员的道德决策:“实践社区”模式
Quality Assurance Journal Pub Date : 2006-12-01 DOI: 10.1002/QAJ.394
T. D. Pearson, James Aldridge, M. Winkel
{"title":"Moral decision‐making among professionals in the pharmaceutical industry: a ‘communities of practice’ model","authors":"T. D. Pearson, James Aldridge, M. Winkel","doi":"10.1002/QAJ.394","DOIUrl":"https://doi.org/10.1002/QAJ.394","url":null,"abstract":"Ethical decision-making in a major USA pharmaceutical company was studied. One prevailing model for investigating professional ethics has been to assume that the professional domain itself is morally neutral, and that individuals simply deploy their own personal, privately held values within their professions. Our research, however, indicates that the professional context – which we describe by means of the current concept ‘communities of practice’ – plays a significant role in guiding how these researchers and project managers express their beliefs about what is appropriate behavior in their own profession. We further discovered that it is quite possible to overlook the influence of a community of practice in shaping a moral perspective, owing to differences in the way testing instruments frame the questions. We conclude that in organizations involving an identifiable community of professionals, Quality Assurance programs may face unnecessary obstacles if they neglect attention to the community's culture. Copyright © 2006 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"30 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2006-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126505722","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
The process for implementation of a Quality Management System within a multi‐functional cereal laboratory 多功能谷物实验室质量管理体系的实施过程
Quality Assurance Journal Pub Date : 2006-12-01 DOI: 10.1002/QAJ.392
R. Ferguson, R. Henry, P. Inkerman
{"title":"The process for implementation of a Quality Management System within a multi‐functional cereal laboratory","authors":"R. Ferguson, R. Henry, P. Inkerman","doi":"10.1002/QAJ.392","DOIUrl":"https://doi.org/10.1002/QAJ.392","url":null,"abstract":"The intent of this study was to design, document and implement a Quality Management System (QMS) into a laboratory that incorporated both research and development (R&D) and routine analytical activities. In addition, it was necessary for the QMS to be easily and efficiently maintained to: (a) provide documented evidence that would validate the system's compliance with a certifiable standard, (b) fit the purpose of the laboratory, (c) accommodate prevailing government policies and standards, and (d) promote positive outcomes for the laboratory through documentation and verification of the procedures and methodologies implemented. Initially, a matrix was developed that documented the standards' requirements and the necessary steps to be made to meet those requirements. The matrix provided a check mechanism on the progression of the system's development. In addition, it was later utilised in the Quality Manual as a reference tool for the location of full procedures documented elsewhere in the system. The necessary documentation to build and monitor the system consisted of a series of manuals along with forms that provided auditable evidence of the workings of the QMS. \u0000 \u0000Quality Management (QM), in one form or another, has been in existence since the early 1900's. However, the question still remains: is it a good thing or just a bugbear? Many of the older style systems failed because they were designed by non-users, fiercely regulatory, restrictive and generally deemed to be an imposition. It is now considered important to foster a sense of ownership of the system by the people who use the system. The system's design must be tailored to best fit the purpose of the operations of the facility if maximum benefits to the organisation are to be gained.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"24 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2006-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133488056","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
GLP SOPs for equipment calibration and maintenance part 3: process mapping for SOP development 设备校准和维护的GLP标准操作规程，第3部分:标准操作规程制定的过程图
Quality Assurance Journal Pub Date : 2006-12-01 DOI: 10.1002/QAJ.391
I. Colligon, M. Rosa
{"title":"GLP SOPs for equipment calibration and maintenance part 3: process mapping for SOP development","authors":"I. Colligon, M. Rosa","doi":"10.1002/QAJ.391","DOIUrl":"https://doi.org/10.1002/QAJ.391","url":null,"abstract":"Ask almost anyone who has been involved in writing Standard Operating Procedures (SOPs) about how they learned to do it and chances are the answer will be that they just sat down and wrote their ideas, maybe using a standard format. Although process flows and flow charts have been an integral part of the computer world for as long as most care to remember, it has only been in the past decade or so that the concepts of process design and process flows have started to enter the realm of SOP development in the pharmaceutical industry. In this installment of the series, we will describe one process design approach to developing SOPs for a laboratory. Copyright © 2006 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"102 6 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2006-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130734076","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
European Qualified Person Association 欧洲合格人士协会
Quality Assurance Journal Pub Date : 2006-12-01 DOI: 10.1002/QAJ.387
Wolfgang Heimes
{"title":"European Qualified Person Association","authors":"Wolfgang Heimes","doi":"10.1002/QAJ.387","DOIUrl":"https://doi.org/10.1002/QAJ.387","url":null,"abstract":"","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"41 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2006-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116974169","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
Integrating maintenance activities and Quality Assurance in a research and development (R&D) system 在研发(R&D)系统中集成维护活动和质量保证
Quality Assurance Journal Pub Date : 2006-12-01 DOI: 10.1002/QAJ.388
D. Basak
{"title":"Integrating maintenance activities and Quality Assurance in a research and development (R&D) system","authors":"D. Basak","doi":"10.1002/QAJ.388","DOIUrl":"https://doi.org/10.1002/QAJ.388","url":null,"abstract":"A well-balanced maintenance program furnishes information and instructions to personnel involved in maintaining existing equipment, provides current information on the availability and location of maintenance materials, improves utilization of labor forces and increases equipment reliability. Planned and preventive maintenance procedures where components are serviced and changed when they approach the end of their useful lives can be augmented by suitable means, which continuously check vital machine functions. Quality Assurance can be seen as a management system that brings maintenance activities undertaken by all parties under control with the aim of preventing things from going wrong and costing time, effort and money to put them right. An attempt has been made to highlight the integration of maintenance activities with Quality Assurance as a whole in a research and development (R&D) system.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"4 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2006-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131044181","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
Strengthening GLP compliance through internal audits 通过内部审计加强GLP合规性
Quality Assurance Journal Pub Date : 2006-12-01 DOI: 10.1002/QAJ.390
Henry Li, D. Pifat, Gerald L. Klein, S. Petteway
{"title":"Strengthening GLP compliance through internal audits","authors":"Henry Li, D. Pifat, Gerald L. Klein, S. Petteway","doi":"10.1002/QAJ.390","DOIUrl":"https://doi.org/10.1002/QAJ.390","url":null,"abstract":"The Quality Assurance (QA) strategy for assessing Good Laboratory Practice (GLP) compliance at different testing facilities varies from focusing on study data verification to taking a quality system approach. As a best practice and to ensure overall compliance with GLP regulations, the Quality Assurance Unit (QAU) should perform three types of internal audits: study-specific, process-based, and system inspection. These internal audits serve as a tool to ascertain whether a GLP compliance program is functioning correctly. Information gathered from these audits can also be used to provide assistance during the evolution of a new GLP compliance program. As the GLP compliance program matures, internal audits can be a useful mechanism to help maintain compliance and promote continued improvement. Copyright © 2006 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"49 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2006-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123340990","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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