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

{"title":"Biologically based validation of PC electrophysiology data collection systems utilizing the Good Automated Laboratory Practices.","authors":"R D Jones,&nbsp;T A Weyrauch,&nbsp;S R Bailey,&nbsp;C A Halder","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Since there was a scientific need to conduct electrophysiology measurements to detect possible ocular (electroretinography, ERG), central neurotoxic (quantitative electroencephalography, qEEG), and cardiac (electrocardiography, ECG) effects in animals used in certain regulatory studies, the acquisition of suitable automated PC software systems were required. This article describes the process by which these systems were validated to ensure that they met the scientific requirements, while also addressing the principles of Good Automated Laboratory Practices (GALP). After a thorough search of existing commercial packages, a plan was developed specific for each PC-based collection system selected for evaluation. The common elements of each plan included consideration of both scientific and GALP elements, such as necessary biological response variables, raw data acquisition and identification, acceptance criteria, security, protection, storage media, data integrity, audit requirements and standard operating procedures. The authors' approach to validation for each electrophysiology system was to determine scientific needs for accuracy, precision, and detection limit of biological effects concurrent with GALP requirements. The selected software systems were employed in separate scientific GLP studies conducted in dogs, rats, and mini-pigs to demonstrate the ability to detect cholinesterase effects due to multiple infusions of physostigmine, based on parallel measurement of cholinesterase biomarkers. Since the systems were designed for human usage, certain adaptations were necessary. A critical assumption to be tested was the ability of the system's algorithms to adequately capture and assimilate the data in an accurate fashion. Concomitantly, the related GALP needs, such as data integrity, security, CD-ROM archive, and personnel training requirements were evaluated, implemented, and defined to accommodate the application and process needs. The biological approach to validation of these PC-based electrophysiology systems met the necessary scientific acceptance criteria as well as compliance requirements in order to be used in regulatory studies.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"5 1","pages":"1-17"},"PeriodicalIF":0.0,"publicationDate":"1997-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"20117569","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":"Toxicological considerations in environmental audit studies.","authors":"F N Jaffery,&nbsp;V Misra,&nbsp;P N Viswanathan","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Environmental auditing has emerged as a new industrial management tool in recent years. It involves a careful examination of the organization, management procedures, product development, and equipment for environmental protection. The purpose of an environmental audit, from the toxicological point of view, is to assure that the total risk to humans, material, and environment should not increase as a result of a chemical process. The criteria to be adopted for such a safety audit are outlined.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"5 1","pages":"19-26"},"PeriodicalIF":0.0,"publicationDate":"1997-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"20116938","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 procedure for assessing a contract testing facility: one sponsor's perspective.","authors":"M M Twitty,&nbsp;S A Martin,&nbsp;J L Henry,&nbsp;L J Nowicki,&nbsp;M J Dabrowski,&nbsp;L M Veresh","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The government agencies responsible for Good Laboratory Practices (GLP) place accountability for assuring compliance of studies intended for submission on the sponsor. An initial step toward meeting these legal obligations includes a comprehensive assessment of the candidate testing facility. Literature review has substantiated that the initial evaluation may be best accomplished through both technical and compliance-focused inspections (O'Brien-Pomerleau, 1991; Schroeder, 1989). Combined technical and compliance inspections have also been reported as an effective auditing approach for long-term studies (Hoover and Baldwin, 1984). However, for the purposes of the initial qualifying assessment inspection, personal experiences and published literature indicate that these two equally important evaluations are commonly conducted independently of one another (Scozzie, 1995). A collaborative approach utilized by Dow Corning Corporation in the preliminary assessment of a contract testing facility builds upon those methods just mentioned. Coupling this evaluation with a program of actively monitoring the testing facility's performance in study conduct provides continued assessment and has proven to be beneficial to all stakeholders (sponsor, testing facility, and regulatory agency). Details of the process practiced by this sponsor to assure that studies conducted by a contract testing facility meet GLP requirements are presented.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"5 1","pages":"61-8"},"PeriodicalIF":0.0,"publicationDate":"1997-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"20116937","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":"Developing a consensus on quality criteria.","authors":"R S DeWoskin","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"5 1","pages":"v-vii"},"PeriodicalIF":0.0,"publicationDate":"1997-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"20116936","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 soil characterization--the laboratory.","authors":"V Isaman","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Good laboratory practices (GLP) for field studies have been implemented to provide accurate and complete data in all phases of field trials, including the characterization of the soil where the test system is grown. The soil characterization analysis generally offers two packages or series of analyses from which the sponsor may select. The Series I soil characterization is more comprehensive than the Series II. The Series II characterization includes pH, percent organic matter, cation exchange capacity (CEC), bulk density, percent sand-silt-clay, U.S. Department of Agriculture textural class, and 1/3-bar water-holding capacity. In addition to these analyses, the Series I characterization includes: 15-bar water-holding capacity, and percent total nitrogen, phosphorus, and soluble salts.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"5 1","pages":"49-53"},"PeriodicalIF":0.0,"publicationDate":"1997-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"20116935","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":"GMP criteria for retest and failure analysis. Handling out-of-specification results in the pharmaceutical quality control laboratory.","authors":"A E Klein,&nbsp;M L Rocci","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The Food and Drug Administration's current Good Manufacturing Practices guidelines for the inspection of pharmaceutical quality control laboratories stress the need for explicit standard operating procedure's requirements for retesting criteria and the investigation of specification failures. Out-of-specification results are best handled through a priori procedures for the evaluation of their validity. These procedures should also specify the degree of retesting or resampling permitted. Initial investigations should focus on uncovering apparent laboratory-related or sampling errors. Should this initial investigation prove inconclusive, an expanded investigation should be conducted to uncover any less conspicuous cause, which could include process or operator-dependent as well as analytical errors. A schematic approach to controlling retesting through a rigorous policy of investigating failures, limiting retest analyses, and documenting and reporting all results is described.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"4 4","pages":"247-51"},"PeriodicalIF":0.0,"publicationDate":"1995-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"19855659","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 auditing of chromatographic data.","authors":"F M Pattillo,&nbsp;P H Carver,&nbsp;M A Brewster","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>We have developed a method for consistent, in-depth audit of the integrity of chromatographic records. The approach includes definition of the analyte, the method of analyte sample preparation and analysis, and the analyte concentration range. Acceptance criteria (if any) defined in the protocol or method are compared to the data. Run parameters are compared to those specified in the methodology. Certification of the standard is verified and the limit of quantitation for each run is identified and compared to data. Reasons for data discard and/or reassay are examined. If calculation software is not validated, representative calculations are recomputed and chromatograms are examined for attributability. These parameters are examined in addition to other Good Laboratory practice considerations such as sample identity, sample integrity, and transcription accuracy.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"4 4","pages":"358-60"},"PeriodicalIF":0.0,"publicationDate":"1995-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"19854890","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":"Developing an effective toxicology/quality assurance partnership. Improving quality, compliance, and cooperation.","authors":"R W Usher","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Toxicology and Quality Assurance (QA) at Eli Lilly and Company are well integrated, yet still independent organizations that are aligned with the same overall business objective: to efficiently deliver a high-quality product to the customer. One of the keys to success has been the implementation of a monitoring/metric and trend analysis program of key work processes that are central to the delivery of final product. Our metrics program indicates that the multiple changes that we have made have resulted in a higher quality product. This paper will discuss the practical changes we have made as a part of our Total Quality journey. This article is based solely on the authors' experiences while at Eli Lilly and Company.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"4 4","pages":"308-15"},"PeriodicalIF":0.0,"publicationDate":"1995-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"19854980","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":"The Unites States Department of Agriculture Regulation of Veterinary Biological Products. The use of prelicensing evaluation and postlicensing monitoring to achieve regulatory compliance.","authors":"R E Hill,&nbsp;D C Randall","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The United Stated Department of Agriculture is responsible for regulating veterinary biological products in the United States, and the regulatory authority is provided in the Animal Virus-serum-Toxin Act of 1913. The act authorizes the Secretary of Agriculture to promulgate regulations for the production, testing, and marketing of veterinary biological products into, within, or from the United States. The current regulatory program consists of extensive prelicensing review of products, labeling, facilities, and personnel and a postlicensing monitoring system of unannounced in-depth inspections, premarketing control of product batches (serials), random check testing of finished product, and postmarketing epidemiological surveillance. This combination of regulatory oversight before and after licensure assures that pure, safe, potent, and effective veterinary biologics are available for use in the United States.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"4 4","pages":"323-8"},"PeriodicalIF":0.0,"publicationDate":"1995-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"19854983","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 initiative at the U.S. Department of Agriculture National Veterinary Services Laboratories.","authors":"R E Hill,&nbsp;P F Ross","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The National Veterinary Services Laboratories (NVSL) provides laboratory support and technical assistance for animal health programs of the United States Department of Agriculture. During this past year, the NVSL completed strategic planning activities and identified improved quality assurance (QA) as one of the key elements. The specific QA goal was the establishment of an internationally recognized QA program at the NVSL by the year 2000. This article provides a brief summary of the mission of the NVSL and the short- and long-term goals of the QA initiative.</p>","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"4 4","pages":"319-22"},"PeriodicalIF":0.0,"publicationDate":"1995-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"19854982","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}