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

Multimedia data from two probability-based exposure studies were investigated in terms of how censoring of nondetects affected estimation of population parameters and associations. Appropriate methods for handling censored below-detection-limit(BDL)values in this context were unclear since sampling weights were involved and since bivariate associations/measures were of interest. Both simple substitution(e.g., using 1/2 or 2/3 of the detection limit(DL)for BDL values)and truncation-based strategies were investigated by creating some artificial DLs and comparing resultant estimates with the original studies'uncensored results. The substitution methods generally outperformed the truncation methods, with the(2/3)DL substitution generally performing best.

Monitoring the emissions flux of contaminant gases from large area sources requires measurement of concentrations from an optical remote sensing device and reconstruction of the plume. Path integrated concentrations are determined using multiple optical beam paths. The spatial distribution of concentrations is generated for a plane perpendicular to the direction of the wind. Estimates of the emission flux are determined by integrating the product of the calculated concentrations and wind speeds over the plane. No standard method exists for the complete process, defensible estimates of the uncertainty of the final emission flux have not yet been developed, and a data validation procedure is needed. Auditors are challenged to configure an adequate performance evaluation standard that is representative of a large area source.

Pharmaceutical companies, over a period of time, have attempted to use innovative and modern technologies for quicker and more efficient methods of clinical data capture and analysis. In today's scenario, Electronic Data Capture (EDC) is considered to be the preferred technology that can provide significant benefits over existing manual methods. This article highlights the lacunae of the traditional data capture method and discusses the advantages of using EDC for better data quality, improved performance and productivity, and reduced cost in clinical trial management. It also emphasizes the need for IT infrastructure, training, and 21 CFR Part 11 compliance issues. The authors have also described the challenges to be faced by the investigators and sponsors in implementing EDC. Finally, the article concludes emphasizing the fact that EDC is the future mantra for the clinical trials and all stake holders should face challenges of infrastructure, technology, regulations, and training to make it a success.

Multimedia data from two probability-based exposure studies were investigated in terms of how missing data and measurement-error imprecision affected estimation of population parameters and associations. Missing data resulted mainly from individuals'refusing to participate in certain measurement activities, rather than from field or laboratory problems; it suggests that future studies should focus on methods for maximizing participation rates. Measurement error variances computed from duplicate-sample data were small relative to the inherent variation in the populations; consequently, adjustments in nonparametric percentile estimates to account for measurement imprecision were small. Methods of adjustment based on lognormality assumptions, however, appeared to perform poorly.

This article presents a simple, semi-prescriptive self-assessment model for use in industry as part of a continuous improvement program such as Total Quality Management (TQM). The process by which the model was constructed started with a review of the available literature in order to research TQM success factors. Next, postal surveys were conducted by sending questionnaires to the winning organisations of the Baldrige and European Quality Awards and to a preselected group of enterprising UK organisations. From the analysis of this data, the self-assessment model was constructed to help organisations in their quest for excellence. This work confirmed the findings from the literature, that there are key factors that contribute to the successful implementation of TQM and these have different levels of importance. These key factors, in order of importance, are: effective leadership, the impact of other quality-related programs, measurement systems, organisational culture, education and training, the use of teams, efficient communications, active empowerment of the workforce, and a systems infrastructure to support the business and customer-focused processes. This analysis, in turn, enabled the design of a self-assessment model that can be applied within any business setting. Further work should include the testing and review of this model to ascertain its suitability and effectiveness within industry today.

Laboratory Information Management Systems (LIMS) play a key role in the pharmaceutical industry. Thorough and accurate validation of such systems is critical and is a regulatory requirement. LIMS user acceptance testing is one aspect of this testing and enables the user to make a decision to accept or reject implementation of the system. This paper discusses key elements in facilitating the development and execution of a LIMS User Acceptance Test Plan (UATP).

There has been a significant increase in the number of clinical drug trials (particularly phase III) being conducted in developing countries for infectious diseases such as HIV, malaria, and tuberculosis. Laboratory results provided by medical testing laboratories in the region are critical to ensuring the safety of patients and the generation of good quality data. A number of well accepted Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) guidelines govern the conduct of clinical trials internationally. Good Clinical Practice guidelines remain too vague with respect to sample analysis to ensure practical implementation in these laboratories. In their strictest sense, Good Laboratory Practice guidelines refer to the analysis of samples from non-clinical studies. A specific set of minimum standards or requirements for practical implementation of clinical trial requirements in medical testing laboratories in the developing world is urgently required.

It is generally accepted that the method detection limit or MDL (defined in 40 CFR 136, Appendix B) provides protection against false positives 99% of the time. This is correct, but only for the next single measurement performed after the MDL is determined. Subsequent measurements are not protected against false positives with the same degree of confidence, and there is no protection for false negatives. This paper provides a simple cost-effective approach for estimating the "reliable detection limit." Unlike the MDL, the statistic may be used for an indefinite number of future measurements and minimizes false negatives.

This paper outlines the development of a CD-ROM training package entitled: The WHO Basic Training Modules on GMP, intended to support the creation of training courses aimed particularly at government compliance officials who inspect pharmaceutical manufacturing facilities. The material was created over a three-year period in collaboration with a team of external experts, WHO regional and local offices, and Drug Regulatory Authorities of participating countries. The nine training workshops and courses that contributed to the development and evaluation processes were attended by approximately 240 participants from 47 countries. To date over 5,800 copies of the CD-ROM have been distributed.

The Internet continues to provide an excellent resource for information on quality assurance concepts, regulations, and practices. A search using just the word "quality" produced over 42 million hits. The combination of "quality" and "assurance" yielded over 2 million hits. Presented here is a sampling of 100 quality assurance sites organized alphabetically by site name, and accompanied by a brief description of the information available at the site. The choice of which sites to include was based on the author's experience and familiarity with the QA profession, and was aimed towards providing examples in active areas of QA including business and manufacturing, good practice regulations (i.e., GxPs), information quality, medical practice, software quality, higher education, and quality of research. The 100 sites provide access to a broad array of documents, services, forums, and opportunities to exchange ideas, and include links to major national regulatory and standard setting bodies around the world.