MedWorm.com provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest items from the 'The Quality Assurance Journal' source. Wed, 07 Dec 2011 23:13:01 +0100 http://www.medworm.com/index.php?rid=5266987&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.482 AbstractSampling is an inevitable means of testing in quality inspections. However sampling is always associated with sampling risks that inspectors have to control. This paper aims to reveal the reliability and efficacy of the commonly used formula, ‘Square root of N plus one’, in lot acceptance sampling. An Operating Characteristic Curve is exploited to test the validity of the sampling plan and it offers a further dimension to unveil the unreliability of it. The probability of accepting a defective lot is increased substantially from larger to smaller lot sizes with the deployment of the √N + 1 rule as a sampling plan. Using a sampling plan blindly from recognized sources and pursuing a traditional practice does not ensure that the sampling plan is statistically valid. Regardless ... The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=5266987 Wed, 28 Sep 2011 04:00:00 +0100 5266987 http://www.medworm.com/index.php?rid=5266988&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.488 This article provides an advisory approach regarding how to avoid an FDA Warning Letter following the receipt of a significant Form FDA 483. The focus is on the 483 response as it applies to GCP but can be applied to the response to the Warning Letter itself as well as a wider scope of GXP (GMP, GLP, GCP) inspection and audit responses. Copyright © 2011 John Wiley & Sons, Ltd. (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=5266988 Tue, 27 Sep 2011 04:00:00 +0100 5266988 http://www.medworm.com/index.php?rid=5244828&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.484 This study was aimed to identify factors affecting drug quality problems. Odds ratio (OR) and 95% confidence intervals (CIs) were used through a logistic regression model to determine association between 4 M factors (man, machine, materials and methods) and drug quality problems (physical appearance changes, labeling problems, packaging problems and packing problems). We found that two factors, man and material, were mainly associated with drug quality problems. Among other man factors, ‘inspector checking the finished products’ was the leading cause for labeling problems. Likewise, aluminum foil was responsible for packaging problems among other material factors. We conclude that drug manufacturers should consider using detector and barcode systems to reduce human errors and use goo... The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=5244828 Wed, 21 Sep 2011 04:00:00 +0100 5244828 http://www.medworm.com/index.php?rid=5216680&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.483 SummaryEthics committee supervision is an essential part of conducting clinical trials and is required to ensure compliance with the international recommendations including the Declaration of Helsinki, International Conference on Harmonisation Good Clinical Practice (ICH GCP), Directive 2001/20/EC of the European Parliament and Council and WHO recommendations etc. No clinical trial can be initiated without prior review and approval from an ethics committee. In addition to expert evaluation of planned clinical trials, ethics committees are responsible for providing regular monitoring of clinical trial compliance with the international and national ethic, moral and legal aspects throughout the whole process of the trial conduct. Copyright © 2011 John Wiley & Sons, Ltd. (Source: The Qual... The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=5216680 Mon, 12 Sep 2011 04:00:00 +0100 5216680 http://www.medworm.com/index.php?rid=5016089&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.466 SummarySpreadsheets are widely used for the storage, processing and reporting of data. As these spreadsheets are associated with the conduct of non‐clinical safety studies intended for regulatory submission, it is essential that they should be developed, validated, operated, maintained, retired and archived in accordance with the OECD Principles of GLP.The present document provides guidance, i.e. a basic strategy for GLP‐compliant development and validation of spreadsheets. Different approaches can also be used, as long as they are compliant with the OECD Principles of GLP.The AGIT (Arbeitsgruppe Informations‐Technologie) is a working group consisting of representatives from Swiss industry and Swiss GLP monitoring authorities that proposes strategies relating to information technolog... The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=5016089 Thu, 07 Jul 2011 23:00:00 +0100 5016089 http://www.medworm.com/index.php?rid=4860111&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.465 In this study, the implementation of the ISO/IEC 17025 standard in a Transformer Oil Testing Laboratory (TOTL) for performing the Electrical Breakdown Voltage was evaluated. The application of such a QA system involves a great deal of human resources, top management commitment, organizational effort, expertise and expense. Three years of experience of working under the ISO/IEC 17025 compliant quality system is described. The enhanced reliability of the test results, the technical competence of TOTL staff, the increased trust and satisfaction of established customers and the improved reputation of the TOTL are important gains that are attained from the application of the ISO/IEC 17025 standard. Conversely, the drawbacks that resulted from implementing and maintaining the ISO/IEC 17025 QA sy... The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=4860111 Mon, 23 May 2011 23:00:00 +0100 4860111 http://www.medworm.com/index.php?rid=4640360&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.464 AbstractA large number of clinical documents are generated during the clinical stage of drug development. These documents are used to obtain regulatory permission for clinical trial initiation, to execute clinical trials, and eventually to get regulatory approval for new products or indications. The types of clinical documents required are numerous and complex and include study protocols, informed consent forms, investigator brochures, investigational new drug annual reports, and clinical study reports. In addition, clinical documents that summarize clinical study results are part of a new drug application or biological license application. Because clinical documents are critical for drug development and business, they must be of the highest quality. Towards that end, we have developed a c... The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=4640360 Sun, 27 Mar 2011 00:00:00 +0100 4640360 http://www.medworm.com/index.php?rid=5415779&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.485 AbstractIn the pharmaceutical industry qualification of HVAC systems is done by using a risk based approach. Failure mode effect analysis (FMEA) concepts were used for risk assessment of a HVAC system to determine the scope and extent of qualification and validation in this present work. The HVAC is the “direct impact” system in the aseptic practice which directly affects the product quality and regulatory compliance. The level of risk associated with the HVAC system was assessed based on the impact and severity of the probable risk in aseptic practice in sterile manufacturing. On completion of the risk assessment, control and measures developed and recommended actions for unacceptable risk were identified for improved cGMP compliance and qualification of the system upgrades. After com... The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=5415779 Sat, 01 Jan 2011 05:00:00 +0100 5415779 http://www.medworm.com/index.php?rid=5394700&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.489 In this study the presence of these indicators was evaluated. The monitoring was conducted during the reception of the fish, chilling and storage of the product at −18 °C. As part of the monitoring, preventive measures for each Critical Control Point associated with the program of Hazard Analysis and Critical Control Point were established. The results showed that there was significant difference (p < 0.05) between the samples. The resistance of these microorganisms involved in getting the frozen fillets confirmed the need for more effective control and should be subject to a regulatory program like ISO 22000. This program specifies the requirements needed for a system that can monitor and master hazards and ensure that food is safe for human consumption. Copyright © 2011 John... The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=5394700 Sat, 01 Jan 2011 05:00:00 +0100 5394700 http://www.medworm.com/index.php?rid=5353831&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.474 (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=5353831 Sat, 01 Jan 2011 05:00:00 +0100 5353831 http://www.medworm.com/index.php?rid=5353830&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.486 SummaryThis is the fourth and final part of the Principles in Quality Assurance series. Previous articles discussed the need for steering principles, the definition and application of GLP concepts, and the larger context of a model for effective Quality Assurance. The preceding paper proposed the use of the “Grip/Build/Engage” (GBE) model as a structure to improve the impact of Quality Assurance, giving an overview as well as some details of the “Grip” phase ‐ defining story, structure and standards for Quality Assurance. This current part will review the other components of the GBE model and how Quality Assurance engage to produce the maximum positive impact. Copyright © 2011 John Wiley & Sons, Ltd. (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=5353830 Sat, 01 Jan 2011 05:00:00 +0100 5353830 http://www.medworm.com/index.php?rid=5353829&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.487 (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=5353829 Sat, 01 Jan 2011 05:00:00 +0100 5353829 http://www.medworm.com/index.php?rid=3766502&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.455 Pharmaceutical companies often rely upon web-based electronic Case Report Forms (eCRFs) for clinical investigators to enter trial data at their site. Using web-based technology means that the investigator directly enters data onto the sponsor company's server via the Internet. Does this cause a problem with complying with international standards regarding data integrity? Copyright © 2010 John Wiley & Sons, Ltd. (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=3766502 Mon, 19 Jul 2010 23:00:00 +0100 3766502 http://www.medworm.com/index.php?rid=3617212&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.452 This article presents a curriculum offered by Danube University Krems to individuals to accommodate this educational need. Copyright © 2010 John Wiley & Sons, Ltd. (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=3617212 Mon, 31 May 2010 23:00:00 +0100 3617212 http://www.medworm.com/index.php?rid=3442775&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.450 No Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=3442775 Tue, 06 Apr 2010 23:00:00 +0100 3442775 http://www.medworm.com/index.php?rid=3234661&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.449 This article focuses on preparation of a Clinical Investigator site, immediately prior to FDA inspection. This process can be driven by either the Sponsor or the Clinical Investigator site, but ideally it is a combined approach involving both parties, as well as the Contract Research Organization (CRO) if one is used. This 'last minute' preparation task can arise at any time whereby there is some prior FDA notice of an impending inspection, which often occurs after a clinical trial has been completed, the marketing application has been submitted, the research site is notified directly and/or the Sponsor is asked for additional information concerning specific sites. The author believes that this is not the time for a Quality Assurance (QA) audit but rather a management and organizational ta... The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=3234661 Wed, 03 Feb 2010 00:00:00 +0100 3234661 http://www.medworm.com/index.php?rid=3840952&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.452 (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=3840952 Fri, 01 Jan 2010 00:00:00 +0100 3840952 http://www.medworm.com/index.php?rid=2411804&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.441 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 f... The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=2411804 Fri, 15 May 2009 04:00:00 +0100 2411804 http://www.medworm.com/index.php?rid=2338530&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.442 No Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=2338530 Wed, 01 Apr 2009 04:00:00 +0100 2338530 http://www.medworm.com/index.php?rid=4080873&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.460 Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=4080873 Tue, 31 Mar 2009 23:00:00 +0100 4080873 http://www.medworm.com/index.php?rid=4016949&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.459 Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=4016949 Tue, 31 Mar 2009 23:00:00 +0100 4016949 http://www.medworm.com/index.php?rid=4010356&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.458 (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=4010356 Tue, 31 Mar 2009 23:00:00 +0100 4010356 http://www.medworm.com/index.php?rid=3923897&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.457 (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=3923897 Tue, 31 Mar 2009 23:00:00 +0100 3923897 http://www.medworm.com/index.php?rid=3919249&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.456 (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=3919249 Tue, 31 Mar 2009 23:00:00 +0100 3919249 http://www.medworm.com/index.php?rid=3840959&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.448 (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=3840959 Tue, 31 Mar 2009 23:00:00 +0100 3840959 http://www.medworm.com/index.php?rid=3840958&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.446 Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=3840958 Tue, 31 Mar 2009 23:00:00 +0100 3840958 http://www.medworm.com/index.php?rid=3840957&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.445 Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=3840957 Tue, 31 Mar 2009 23:00:00 +0100 3840957 http://www.medworm.com/index.php?rid=3840956&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.444 Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=3840956 Tue, 31 Mar 2009 23:00:00 +0100 3840956 http://www.medworm.com/index.php?rid=3840955&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.443 Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=3840955 Tue, 31 Mar 2009 23:00:00 +0100 3840955 http://www.medworm.com/index.php?rid=3840954&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.441 Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=3840954 Tue, 31 Mar 2009 23:00:00 +0100 3840954 http://www.medworm.com/index.php?rid=3840953&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.447 (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=3840953 Tue, 31 Mar 2009 23:00:00 +0100 3840953 http://www.medworm.com/index.php?rid=3840951&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.455 (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=3840951 Tue, 31 Mar 2009 23:00:00 +0100 3840951 http://www.medworm.com/index.php?rid=1474011&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.424 No Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=1474011 Tue, 01 Apr 2008 04:00:00 +0100 1474011 http://www.medworm.com/index.php?rid=606336&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.400 No Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=606336 Sun, 01 Apr 2007 04:00:00 +0100 606336 http://www.medworm.com/index.php?rid=366266&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.396 No Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=366266 Tue, 16 Jan 2007 07:00:00 +0100 366266 http://www.medworm.com/index.php?rid=366265&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.397 The What's New? section in the Quality Assurance Journal aims to draw attention to items of importance to QA professionals. There is usually a three-month interval between final submission of manuscripts and distribution of the journal. For this issue, the entries in the What's New? section arise from the period of 1 June 2006 to 31 August 2006. If you feel that there is any other new information that should be brought to the attention of readers, please let us know by e-mailing . Copyright © 2006 John Wiley & Sons, Ltd. (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=366265 Tue, 16 Jan 2007 07:00:00 +0100 366265 http://www.medworm.com/index.php?rid=366264&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.387 No Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=366264 Tue, 16 Jan 2007 07:00:00 +0100 366264 http://www.medworm.com/index.php?rid=366263&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.393 No Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=366263 Tue, 16 Jan 2007 07:00:00 +0100 366263 http://www.medworm.com/index.php?rid=366262&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.391 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. (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=366262 Tue, 16 Jan 2007 07:00:00 +0100 366262 http://www.medworm.com/index.php?rid=366261&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.394 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... The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=366261 Tue, 16 Jan 2007 07:00:00 +0100 366261 http://www.medworm.com/index.php?rid=366260&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.392 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 ... The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=366260 Tue, 16 Jan 2007 07:00:00 +0100 366260 http://www.medworm.com/index.php?rid=366259&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.390 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 improvemen... The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=366259 Tue, 16 Jan 2007 07:00:00 +0100 366259 http://www.medworm.com/index.php?rid=366258&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.388 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 integrat... The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=366258 Tue, 16 Jan 2007 07:00:00 +0100 366258 http://www.medworm.com/index.php?rid=366256&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.389 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. (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=366256 Tue, 16 Jan 2007 07:00:00 +0100 366256 http://www.medworm.com/index.php?rid=366254&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.395 No Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=366254 Fri, 01 Dec 2006 07:00:00 +0100 366254 http://www.medworm.com/index.php?rid=230498&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.386 No Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=230498 Wed, 11 Oct 2006 22:07:01 +0100 230498 http://www.medworm.com/index.php?rid=230497&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.382 The What's New? section in the Quality Assurance Journal aims to draw attention to items of importance to QA professionals. There is usually a three-month interval between final submission of manuscripts and distribution of the journal. For this issue, the entries in the What's New? section arise from the period of 1 March 2006 to 31 May 2006. If you feel that there is any other new information that should be brought to the attention of readers, please let us know by e-mailing . Copyright © 2006 John Wiley & Sons, Ltd. (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=230497 Wed, 11 Oct 2006 22:07:01 +0100 230497 http://www.medworm.com/index.php?rid=230496&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.385 No Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=230496 Wed, 11 Oct 2006 22:07:01 +0100 230496 http://www.medworm.com/index.php?rid=230495&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.380 No Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=230495 Wed, 11 Oct 2006 22:07:01 +0100 230495 http://www.medworm.com/index.php?rid=230494&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.379 No Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=230494 Wed, 11 Oct 2006 22:07:01 +0100 230494 http://www.medworm.com/index.php?rid=230493&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.378 This article proposes an alternative and more efficient approach to building a manageable set of procedural/instructional documents that will help an organization meet its scientific and regulatory needs while alleviating the strain that a gargantuan SOP system can put on its personnel.Among the benefits of this approach are: (1) Documents are organized to follow the logical and chronological flow of the activities they describe. (2) Documents can be located quickly. (3) Users will find what they need to know, presented in a concise manner, without superfluous information. (4) Increased usability of the documents since there is a logical structure to delivered information; thus, users can control the level of detail based on their need. (5) Reduced effort for upkeep of individual documents... The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=230493 Wed, 11 Oct 2006 22:07:01 +0100 230493 http://www.medworm.com/index.php?rid=230492&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.377 Maintaining company processes will afford optimum operation and enhance the company's quality management system. A vital part of maintaining processes is their periodic evaluation. An important part of the monitoring and evaluation process is the flow diagram. A detailed flow diagram is an important tool that affords ease in visualizing the total process and is an aid in locating problem areas. The evaluation of a process is broken down into 15 steps. These steps cover gathering pertinent information, such as problem symptoms from knowledgeable sources and carrying these through their route to potential problem areas to the problems, potential causes, and the root cause of the problem. Knowing the problems brings about the need to assess their impact on the process operation as well as wha... The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=230492 Wed, 11 Oct 2006 22:07:01 +0100 230492 http://www.medworm.com/index.php?rid=230491&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.383 With the complexity of today's studies, it has become increasingly critical that Study Directors understand all disciplines involved in studies under their responsibility. Every phase of a study directly impacts the outcome. If the Study Director does not have sufficient expertise to evaluate problems and issues in all areas as they occur, then study integrity is compromised. The physical location of the Study Director in a multi-site study is of less importance than the education, experience and expertise of that individual. The Study Director must be the single point of control and truly qualified to evaluate all the phases of the study, troubleshoot problems, draw appropriate conclusions, tie all aspects together and write the final report. Copyright © 2006 John Wiley & Sons, Ltd. (Sou... The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=230491 Wed, 11 Oct 2006 22:07:01 +0100 230491 http://www.medworm.com/index.php?rid=230490&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.376 Regulatory requirements for veterinary clinical studies have developed over the last 24 years. This paper covers the current best practice for the clinical study monitor. It describes and qualifies these activities as outlined in the International Conference on Harmonization of Technical Requirements for Registration of Veterinary Products (VICH) Good Clinical Practice (GCP) guidelines (GL9). Copyright © 2006 John Wiley & Sons, Ltd. (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=230490 Wed, 11 Oct 2006 22:07:01 +0100 230490 http://www.medworm.com/index.php?rid=230489&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.384 No Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=230489 Fri, 01 Sep 2006 06:00:00 +0100 230489 http://www.medworm.com/index.php?rid=208004&cid=s_33685_51_f&fid=33685&url=http%3A%2F%2Fdx.doi.org%2F10.1002%252Fqaj.363 No Abstract (Source: The Quality Assurance Journal) The Quality Assurance Journal journals http://www.medworm.com/rss/comments.php?id=208004 Sat, 01 Apr 2006 07:00:00 +0100 208004