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

In the early 1980's both the Environmental Protection Agency and the Food and Drug Administration were receiving studies on the products that they regulate that were unscientifically sound, some even being fraudulent. Studies were being submitted that had not been done under sound scientific practice; data were missing; necessary documentation to reconstruct the study, also known as an audit trail, was not in place, it was this evidence that lead to the Good Laboratory Practice Standards (GLPs) being codified and becoming regulation. The GLPs were meant to assure that studies submitted to the agencies for the registration of products for which they were responsible would protect the environment, and, the safety and health of the public.

Side-by-side comparisons are an effective way to compare different GLP standards. These comparisons allow easy elucidation of differences in the regulations. A side-by-side comparison of the EPA, GLPs and the IMAFF GLPs was constructed and evaluated. The major differences are reported.

Improving health care quality requires the availability of data to identify and eliminate unnecessary variations in the care process. Variations can be caused by an ineffective implementation of research findings or by obstacles to the translation of research into clinical practice. The analysis of current patterns of care by the use of routine data from electronic patient records or clinical registries may help highlight these deficiencies in actual care. The growing infrastructure of information technologies and the knowledge about clinically relevant variations of routine practice may help us understand the mechanisms that are impeding the translation of research into practice. There is a need to scrutinize these variations of practice and the barriers to guideline implementation. We think that an understanding and open discussion of such reasons may help, to continuously improve the quality of patient care. This process facilitates efforts and strategies to implement evidence-based medicine in the daily routine.

Both the United States Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) have issued regulatory documents that address the issues and requirements concerning electronic reporting to the Agencies. EPA has published two comprehensive and useful electronic data interchange (EDI) guidelines: 1) the EPA Electronic Data Interchange (EDI) Implementation Guideline, Draft of September 23, 1994 and October 18, 1994 that is available at the following EPA web site address: www.epa.gov/oppeedi1/guidelines/general.pdf and 2) the Interim Final Notice, Filing of Electronic Reports via Electronic Data Interchange, September 4, 1996, Federal Register Notice [FRL-5601-4, Volume 61, Number 172, page 46684], also available at: www.epa.gov/oppeedi1/edipoli.htm. The FDA has published a guidance document titled, "Guidance for Industry, Computerized Systems Used in Clinical Trials, April 1999" that is available at FDA's web site: www.fda.gov/ora/compliance_ref/bimo/ffinalcct.++ +htm. FDA's guidance document addresses a number of issues for electronic records that are applicable to all areas of GLP compliance. Another FDA document presently under development is titled, "Electronic Standards for the Transmission of Regulatory Information (ESTRI) Gateway." The ESTRI document defines strategic plans for electronic submissions to FDA. FDA has published a guidance document in this area titled, "Guidance for Industry: Providing Regulatory Submissions in Electronic Format--General Considerations, January 1999." This guidance document is available at: www.fda.gov/cder/guidance/index.htm. FDA has also published an important final rule applicable to all electronic records and signatures that is part of the U.S. Title 21 Code of Federal Regulations (CFR), Part 11, titled, "FDA's Final Rule, Electronic Records; Electronic Signatures, effective August 20, 1997." This FDA ruling is discussed below and is available at: www.fda.gov/cder/esig/index.htm.

The service sector within the biopharmaceutical industry has experienced phenomenal growth over the past decade. In the highly regulated Good Laboratory Practices environment, the need for timely, high-quality service, accurate results, and on-time deliverables becomes paramount for the success and profitability of biopharmaceutical companies. The quality assurance process is a vital component of this drug product-development cycle and ensures compliance to the highest domestic and international regulatory standards. Quality-assurance professionals historically have held the role of independent auditors of the processes, who certify that results meet current standards of practice. Covance, a contract research organization that includes Good Laboratory Practices laboratories, reorganized and expanded the functional responsibilities of its quality assurance team in 1997. Auditors and quality assurance professionals have assumed roles beyond traditional compliance auditing and are forging new leadership and mentoring roles as process-improvement specialists. The results have been tangible, measurable benefits for clients and the Covance organization. This article provides an overview of this cultural change and the processes put in place to improve efficiency, productivity, and customer and employee satisfaction.

The Korean Society of Good Laboratory Practice (KSGLP) was established Dec. 10, 1998. The objectives of the KSGLP are to enhance the quality of domestic studies and the level of GLP compliance, in safety testing, and to promote information exchange among its members. The activities of KSGLP include: offering workshops and symposiums, linking with related governmental organizations, collecting GLP related information and providing the information to the related organizations, building international networks to collect information and to establish relationship, developing training materials and publishing periodicals, and other business necessary to achieve the objectives of the KSGLP. The KSGLP achieved its goals within a short period of time by offering workshops and symposia, and by providing important GLP related information in newspapers or via the KSGLP's internet homepage (www.ksglp.or.kr). The main role of the KSGLP will be to disseminate GLP technology nationwide. The KSGLP would like to help many labs that are preparing their facilities for GLP compliance. Further, the KSGLP is hoping to share GLP experiences with other members.

The Quality Assurance Unit analyzed 18 months of departmental data regarding the report-audit cycle. Process mapping was utilized to identify milestones in the cycle for measurement. Five milestones were identified in the audit cycle, as follows: (1) time from report receipt in quality assurance to start of audit, (2) total calendar days to audit a report, (3) actual person-hours to perform a report audit, (4) time from completion of audit to issuance of report, and (5) total time a report is in quality assurance. An interrelationship diagraph is a quality tool that is used to identify what activities impact the overall report-auditing process. Once the data collection procedure is defined, a spreadsheet is constructed that captures the data. The resulting information is presented in time charts and bar graphs to visually aid in interpretation and analysis. Using these quality tools and statistical analyses, the Quality Assurance Unit identified areas needing improvement and confirmed or dispelled previous assumptions regarding the report-auditing process. By mapping, measuring, analyzing, and displaying the data, the overall process was examined critically. This resulted in the identification of areas needing improvement and a greater understanding of the report-audit cycle. A further benefit from our increased knowledge was the ability to explain our findings objectively to our client groups. This sharing of information gave impetus to our clients to examine their report-generation process and to make improvements.