Quality assurance (San Diego, Calif.)最新文献

{"title":"FIFRA-88, GLP, and QA: pesticide registration.","authors":"R T Sterner,&nbsp;K A Fagerstone","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The 1988 amendment to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA-88) has decreased the number of pesticide registrations in the United States. Subsequent implementation of the U.S. Environmental Protection Agency (EPA) Good Laboratory Practice (GLP) and quality assurance (QA) standards has increased costs of maintaining these registrations. The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) maintains approximately 30 Section 3 (federal) or Section 24c (state) vertebrate pesticide registrations for the Wildlife Services (WS) program to control wild mammals and birds that damage crops, impact endangered species, or pose human health risks. Under FIFRA-88, APHIS summarized, performed, and submitted or gained waivers for > 500 studies requested by the U.S. EPA to assess potential hazards/effects of these pesticides. A summary of FIFRA-88 milestones for registration of 3-chloro-p-toluidine hydrochloride (CPTH), the active ingredient (AI) in a \"low-volume, minor-use\" avicide (DRC-1339, Starlicide), is used to illustrate GLP/QA/animal welfare issues involved in this process. Trends in the development of new pesticides and veterinary drugs are compared to provide some perspectives on future career paths for QA professionals.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"5 3","pages":"171-82"},"PeriodicalIF":0.0,"publicationDate":"1997-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"20432983","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 control for the clinical chemistry laboratory.","authors":"S Ohman","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Since the beginning of the twentieth century, different methods to control the quality of analyses have been in use. The advent of modern analytical instruments has prompted the need for such controls. In a modern clinical chemistry laboratory, quality control is an important tool to maintain the high predictive value of the methods in use. In this article the most important aspects of quality control are outlined. For further study, I recommend the references listed at the end of this article.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"5 2","pages":"79-93"},"PeriodicalIF":0.0,"publicationDate":"1997-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"20363349","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":"Reporting and scheduling in-study inspections with the study director using microsoft Excel.","authors":"T T Kilcoin,&nbsp;D E Mayer","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Our Environmental and Metabolic Fate division conducts a variety of different studies that can require between 1 month and 3 years to complete. Our master schedule for this division can contain as many as 50-75 of these studies. Since the Good Laboratory Practices (GLP) regulations require in-study inspections at intervals adequate to assure study integrity and our quality assurance unit (QAU) standard operating procedure (SOP) requires us to monitor studies that last longer than 3 months at least once a quarter, in-study inspection scheduling can be challenging. In order to keep up with the work load described we have developed a method using a spreadsheet program, Excel, to facilitate in-study inspection scheduling through periodic reporting of all QAU inspection activity to the study director. This report makes the scheduling of critical phase and quarterly inspections a cooperative effort between the study director and QAU auditor. The details of the development and utilization of Excel for these \"in-study inspection tracking reports\" are presented.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"5 2","pages":"133-40"},"PeriodicalIF":0.0,"publicationDate":"1997-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"20363238","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":"Society of Quality Assurance demographic and salary survey.","authors":"D Brodish,&nbsp;M Bandoli,&nbsp;R Smith","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>A demographic and salary survey of the Society of Quality Assurance (SQA) was completed in early 1995. This survey was undertaken by the SQA Board of Publications and is the second to be commissioned by the Society. The SQA survey addressed demographic information, employer information, job description, and salary data. A total fo 399 responses were received--60% from women and 40% from men. The median age of respondents was between 36 and 40 years. Most respondents had at least a bachelor's degree and major fields of training were in the areas of biology and chemistry; however, nearly half responding listed other fields of expertise. Approximately 99% of respondents had at least some Good Laboratory Practices (GLP) experience; however, most had little or no Good Clinical Practice (GCP) or current Good Manufacturing Practice (cGMP) experience. A majority of respondents listed pharmaceuticals, contract research, industry, or chemicals/pesticides/petroleum as best describing their facility. Forty-one percent of respondents were auditors or inspectors (approximately half of all respondents did not supervise others) and 34% were managers or directors. Quality assurance (QA) responsibilities included performing inspections/audits, QA program development, reporting to upper management, and hosting outside auditors. Other activities, such as computer validation, budget management, and archive maintenance, were less frequent. Overall, annual salaries were approximately $20,000 or less (3.6%); $20-30,000 (9.8%); $30-40,000 (20.8%); $40-50,000 (22.6%); $50-60,000 (17.3%); $60-70,000 (10.5%); $70-80,000 (6.9%); and $80,000 or more (8.5%). The median annual salary for the survey was $45-50,000 per year. Salaries increased with education and years of experience. For example, annual salaries ranged from $25-30,000 for 2-5 years of experience to $50-60,000 for > 20 years of experience. Median annual salaries were substantially higher for pharmaceutical and chemical/pesticide/petroleum companies ($50-60,000) compared to contract research laboratories ($35-40,000). Salaries for consultants were highly variable, ranging from under $15,000 per year to > $100,000 per year.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"5 2","pages":"115-24"},"PeriodicalIF":0.0,"publicationDate":"1997-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"20363354","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":"Building a solid GLP foundation: implementing shared training programs between the QAU and study personnel.","authors":"L T Drottar,&nbsp;S L Hopper,&nbsp;J L Masten","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Quality assurance representatives and study personnel are equally responsible for conducting preclinical studies in compliance with good laboratory practices (GLPs). To provide all employees with a solid understanding of GLP requirements we have implemented a system of shared training programs for the quality assurance unit (QAU) and study personnel. Biologists and chemists complete a three-phase training module that encompasses GLP history, roles and responsibilities of the QAU, and QAU procedures specific to Wildlife International, Ltd. Study directors work with experienced QA trainers and are provided mock auditing assignments, including data, reports, and in-process and facility inspections. QA personnel are in turn trained by qualified study personnel in principal scientific concepts, testing guidelines, and study procedures that will be observed when performing in-process inspections and data audits. Also, as permanent positions become available, selected individuals from the QAU may assume responsibilities in various departments as study directors or laboratory supervisors, and study directors may assume responsibilities as quality assurance representatives. At Wildlife International, Ltd., these shared training programs provide a mutual understanding and knowledge of GLP requirements and their application while promoting respect and harmony between the QAU and study personnel.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"5 2","pages":"141-6"},"PeriodicalIF":0.0,"publicationDate":"1997-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"20363240","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":"Integration of occupational health and safety, environmental and quality management system standards.","authors":"A Stromsvag,&nbsp;C Winder","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Occupational health and safety, environmental, and quality (SEQ) issues are commonly managed by three separate departments within organizations. Because of a number of commonalities in the three management systems, there could be a degree of overlap that might lead to inefficiencies. By integrating these three management systems into one SEQ system, the duplication of effort could be minimized and the health and safety, environmental, and quality issues could be managed by one common proactive approach. The draft Australian standard for an occupational health and safety (OHS) management system and the internationally accepted standards for environmental (ISO 14001) and quality (ISO 9001) management systems were analyzed to identify all requirements of the three management systems and integrate this into one SEQ management system standard.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"5 2","pages":"95-113"},"PeriodicalIF":0.0,"publicationDate":"1997-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"20363350","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":"Data organization for soil metabolism and soil degradation studies with microsoft Excel spreadsheets.","authors":"D Lee,&nbsp;B M McCall,&nbsp;N R Lentz,&nbsp;T T Kilcoin","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Certain steps for soil metabolism and soil degradation studies are repetitive and must transpire for each study. These steps are the data on initial combustion of soil, the extraction data, volatile-recovery data, and postextraction soil combustion data. A summary page that includes all these data has been developed and used successfully to document all the raw data associated with these steps on one form. Weights, volumes, and liquid scintillation data can then be entered into an Excel spreadsheet formatted to accept and process these raw data to provide the calculated data required for reporting. This information is centrally located for each sampling time period, which facilitates and streamlines quality assurance (QA) review of this study file. An explanation of the process and examples of the forms is provided.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"5 2","pages":"125-31"},"PeriodicalIF":0.0,"publicationDate":"1997-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"20363353","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":"Integrating quality, safety, and environment management systems.","authors":"C Winder","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Internationally consistent ISO standards are in use, or are being developed, for quality systems, environmental management, and occupational health and safety. These standards outline a model for the management of quality, environment or safety. In many respects the process of developing management systems for these matters contains a number of common elements, including obtaining commitment from senior management; instituting consultative mechanisms; developing a policy; identifying components of the management program; resourcing, implementing, and reviewing the program; and integrating the program into the organization's strategic plan. The necessity of developing separate management systems for different organizational aspects is wasteful and inefficient. Better management systems will be developed if they are integrated into a single management structure.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"5 1","pages":"27-48"},"PeriodicalIF":0.0,"publicationDate":"1997-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"20116934","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 of clinical studies with production drugs.","authors":"J F McCormack","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"5 1","pages":"55-9"},"PeriodicalIF":0.0,"publicationDate":"1997-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"20116939","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 historical progression of the Midwest Regional Chapter of the SQA.","authors":"R C Wilderman,&nbsp;J M Bergquist,&nbsp;V E Alldredge","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The Historical Committee of the Midwest Regional Chapter of the Society of Quality Assurance has recorded and tracked the evolution and historical progression of our chapter from the initial authorization of regional chapters by the national society in 1990, through its growth in membership and area served, to its current status in October 1996. This article describes this growth as well as meeting attendance, location and topics of the training seminars, membership distribution, and the significant milestones accomplished as the chapter journeyed through a whirlwind past.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"5 1","pages":"69-77"},"PeriodicalIF":0.0,"publicationDate":"1997-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"20116940","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}