Quality Assurance Journal最新文献

{"title":"Quality assurance program for spent radioactive sealed sources in Egypt","authors":"Y. T. Mohamed","doi":"10.1002/QAJ.444","DOIUrl":"https://doi.org/10.1002/QAJ.444","url":null,"abstract":"Effective implementation of the Hot Laboratories Center Quality Assurance Program (QAP) is dependent on the efforts at all levels of all participants. Management is responsible for defining quality, developing appropriate plans to attain quality, and supporting the workers in the pursuit of quality. QA organizations of the program participants are responsible for verifying the achievement of quality in the implementation of the Hot Laboratories Center QA program. A written QAP shall be developed, implemented, and maintained. The QAP describes the organizational structure, functional responsibilities, levels of authority, and interfaces for those managing, performing, and assessing the work. The QAP shall describe the management processes, including planning, scheduling, and resource considerations. The organization, responsibilities/authorities of all participants, internal and external interfaces, and lines of communication should be established during the conceptual phase. Quality Assurance (QA) as an essential management tool is being strongly applied in the area of predisposal of Spent Radioactive Sealed Sources (SRSS). Quality Control is now considered as part of the planning and systematic actions of QA. To ensure compliance with the requirements, and to assure the envisaged behavior of the SRSS package and disposal system, a QAP for all stages of SRSS management, including SRSS conditioning, transportation, storage, and disposal are required. Copyright © 2009 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"4 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2009-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121238703","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}

{"title":"Quality assurance management system for spent radioactive sealed sources in Egypt","authors":"Y. T. Mohamed","doi":"10.1002/QAJ.445","DOIUrl":"https://doi.org/10.1002/QAJ.445","url":null,"abstract":"To achieve the overall protection goals set by the regulatory authorities, Quality Assurance (QA) has to take place in every phase of a waste management system. It is the duty of the Hot Laboratories Center (HLC), to develop a quality system starting from the Quality Assurance Management System (QAMS) for all activities concerned with the management and safety of radioactive waste to be confident that the work will be accomplished according to written and approved procedures to protect the public, employees and the environment from any mismanagement of radioactive waste. It is intended that this QAMS document is closely integrated with system planning. As work scope is adjusted to reflect schedule adjustments, resource limitations, or other scope changes due to programmatic considerations, changes or revisions of QA requirements that result will be accomplished by revisions of this QAMS and its subordinate quality plans. The Quality Assurance Program (QAP) is described in planning documents and implementing procedures that contain detailed instructions for each process or activity. The QAP serves as a resource for the technical staff to ensure that the results of the compliance assessment are traceable and reproducible, that accountability is maintained, and that conclusions are based on sound practices. Copyright © 2009 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"45 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2009-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127413872","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}

{"title":"Opportunities, challenges and benefits of using HACCP as a quality risk management tool in the pharmaceutical industry","authors":"S. Dahiya, R. Khar, A. Chhikara","doi":"10.1002/QAJ.446","DOIUrl":"https://doi.org/10.1002/QAJ.446","url":null,"abstract":"Effective quality risk management can facilitate better and more informed decisions, provide regulators with greater assurance of a company's ability to deal with potential risks and can beneficially affect the extent and level of direct regulatory oversight. The Hazard Analysis and Critical Control Points (HACCP) method is now a recognized and useful tool in the pharmaceutical industry to meet the primary principles of quality risk management. Global perspective, forward-looking view, open communication, integrated management, continuous process, shared product vision and teamwork are the principles, which provide a framework to accomplish effective risk management. \u0000 \u0000 \u0000 \u0000The quality risk management process includes risk identification, risk analysis and risk evaluation. Control and reduction of the risk focuses on processes for mitigation or avoidance of quality risk when it exceeds an acceptable level. The quality risk management tools provide documented, transparent and reproducible methods to accomplish the steps of the quality risk management process. \u0000 \u0000 \u0000 \u0000The HACCP methodology aims to prevent known hazards and reduce the risk that they will occur at specific points in the pharmaceutical manufacturing processes. It covers both the Good Manufacturing Practices (GMP) and the safety of the personnel engaged in the manufacturing processes. HACCP is the systematic method (comprised of seven principles) for the identification, assessment and control of safety hazards associated with physical, chemical and biological hazards. The problems associated with the implementation of HACCP may be overcome by training and education in the HACCP system for the personnel engaged in pharmaceutical industry. The HACCP system benefits all, the consumers, industry and the government as it focuses on prevention rather than relying mainly on end product testing. This scientific and systematic system is cost-effective and leads to reduced product loss and wastage, and assures the safety of pharmaceutical products. Copyright © 2009 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"78 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2009-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126113889","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}

{"title":"Validation of commercial computerised systems using a single life cycle document (integrated validation document)","authors":"R. Mcdowall","doi":"10.1002/QAJ.443","DOIUrl":"https://doi.org/10.1002/QAJ.443","url":null,"abstract":"A risk-based approach to the validation of low risk commercially available computerised systems is described. To determine if validation is required, the business process automated by the system is assessed to see if it is regulated. If validation is required, then the Good Automated Manufacturing Practice (GAMP) software category is mapped against the impact of the records generated by the system to determine if full or reduced validation is required. If reduced validation is indicated, the use of a single integrated validation document is proposed and illustrated with two case study examples. The use of a Validation Master Plan (VMP) to facilitate this validation process is also presented and described. Copyright © 2009 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"5 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2009-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127427205","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}

{"title":"A novel audit model for assessing quality in non‐regulated research","authors":"S. Volsen, M. Masson","doi":"10.1002/QAJ.441","DOIUrl":"https://doi.org/10.1002/QAJ.441","url":null,"abstract":"The need for Quality standards in non-regulated research is a matter of considerable current debate. Whilst a number of such guidelines have been developed over recent years, their successful implementation remains a challenge to all. In order to assess whether research standards are indeed improving on the bench following the instigation of such a quality system, a question posed by both senior management and scientists alike, an independent compliance programme is required. However, given the lack of predicate rules, naivety to audit process and general sensitivity to external scrutiny within the scientific ranks, then work in this ‘Grey Area’ generates high exposure for the conventional GLP, GCP or GMP auditor. We have developed, tried, and tested a highly effective, novel audit model for assessing the quality of non-regulated research. This simple system can be applied successfully irrespective of scientific discipline or field. Whilst common principles will always apply during any quality system audit, the refinements and idiosyncrasies we describe here will, as we have found, help underpin success. Our intentional assumption is that this is a first time endeavour for the quality professional. Copyright © 2009 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"39 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2009-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123210406","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}

{"title":"Surf's up!","authors":"T. Jones","doi":"10.1002/QAJ.447","DOIUrl":"https://doi.org/10.1002/QAJ.447","url":null,"abstract":"","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"9 10","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2009-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131868743","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}

{"title":"GLP SOPs for equipment calibration and maintenance. Part 6: implementation of SOPs","authors":"I. Colligon, M. Rosa","doi":"10.1002/QAJ.428","DOIUrl":"https://doi.org/10.1002/QAJ.428","url":null,"abstract":"No one will argue that writing good Standard Operating Procedures (SOPs) is a major undertaking, but success at this task does not guarantee their use and compliance with what they say. In this installment we will look at the critical next step in the life of an SOP: its implementation. Copyright © 2008 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"57 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":"130149047","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}

{"title":"About quality and qualification","authors":"R. Hattemer‐Apostel","doi":"10.1002/QAJ.429","DOIUrl":"https://doi.org/10.1002/QAJ.429","url":null,"abstract":"","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"160 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":"122798375","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}

{"title":"Good Laboratory Practice (GLP)– guidelines for the validation of computerised systems","authors":"Peter M. Esch, G. Donzé, Bruno Eschbach, S. Hassler, Leo Hutter, H. Saxer, U. Timm, R. Zühlke","doi":"10.1002/QAJ.426","DOIUrl":"https://doi.org/10.1002/QAJ.426","url":null,"abstract":"The aim of this document is to provide guidance on the validation of computerised systems, compliant with Good Laboratory Practice (GLP). It specifies more precisely the procedures to follow in carrying out validations of computerised systems. It intends to help test facilities promote a common standard. However, the test facility management may use different approaches, as long as they are in compliance with the Organisation for Economic Co-operation and Development (OECD) Principles of GLP [1]. The extent of a validation may vary depending on the complexity of the computerised system. In any case the validation should demonstrate that the computerised system is suitable for its intended purpose. \u0000 \u0000 \u0000 \u0000The Arbeitsgruppe Informations-Technologie (AGIT) is a working group consisting of representatives from Swiss industry and Swiss GLP monitoring authorities with the aim of proposing procedures that are practical for use in test facilities fulfilling GLP regulatory requirements. These guidelines have been adapted to current practices and replace those issued in June 2000. Copyright © 2008 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"87 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":"114547868","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}

{"title":"Test substance characterization for the EPA: what you've always wanted to know but were afraid to ask","authors":"W. Barta, C. Lee, Maryanne B. Oster, Tammy White","doi":"10.1002/QAJ.431","DOIUrl":"https://doi.org/10.1002/QAJ.431","url":null,"abstract":"The Society of Quality Assurance (SQA) GLP Specialty Section, a member of the SQA Regulatory Forum, is a group of participants from the regulated community which provides insight and guidance to our membership and the regulated community. The Specialty Section has encountered several participants who want to know what types of information and data are needed during an inspection by the US EPA's Office of Enforcement and Compliance Assurance (OECA). The OECA is responsible for monitoring studies submitted to the Office of Pesticide Programs in support of pesticide registrations as defined under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). All submitted studies are to be conducted according to the FIFRA US Good Laboratory Practice Standards (GLPS). The GLPS contain specific language concerning the characterization of test, control and reference substances used in these studies. This article clarifies those requirements and provides perspective on the EPA expectations on meeting those requirements. The topics of discussion include: \u0000 \u0000 \u0000 \u0000regulatory requirements \u0000 \u0000 \u0000 \u0000 \u0000responsibilities of the testing facility management, study director, Quality Assurance Unit and the sponsor \u0000 \u0000 \u0000 \u0000 \u0000preparing for an inspection \u0000 \u0000 \u0000 \u0000 \u0000overview of data to be made available at the time of inspection \u0000 \u0000 \u0000 \u0000 \u0000composition of a Certificate of Analysis. \u0000 \u0000 \u0000 \u0000 \u0000Copyright © 2008 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"33 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":"117315588","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}