Quality assurance summary

In summary, the new 2D experiments of relaxation and diffusion appear to offer a new method to identify and quantify the components in dairy products. The two components are well separated in the 2D maps while they can be heavily overlapped in the ID spectrum. We find that some microscopic properties of the products can be reflected in the relaxation and diffusion properties. These new techniques are likely to be useful to assist the characterization of the products for quality control and quality assurance. 

Therefore, if final, fully quality-assured individual study reports are not available at the time of IND submission, an integrated summary report of toxicological findings based... 

Ozone and ozone precursor concentrations at nonurban locations in the eastern United States were studied extensively. The three parts of the study were field measurements, a quality assurance program, and an airborne monitoring program. The main objective of the study was to establish a data base for nonurban ozone and precursor concentrations. Simultaneous statistical summaries of the concentrations of nitrogen dioxide and nonmethane hydrocarbons were also provided. Another objective was to search for relationships between ozone concentrations and nitrogen dioxide and nonmethane hydrocarbon concentrations. 

In summary an FDEMS sensor system can be used to monitor the processing properties in situ during the fabrication process of a composite part. A smart sensor control system can be used to monitor resin properties for reproducability-quality assurance, to ensure fabric impregnation, and to control and optimize the composite fabrication process intelligently through in situ sensor feedback. 

Wildland Fire Season Summary. Division of Air Quality Air Monitoring and Quality Assurance. State of Alaska Department of Conservation Web site. Available online. URL http // www.dec.state.ak.us/air/am/2004 wf sum.htm. 

The validation master plan is a summary document stating the intention and the methods to be used to establish the adequacy of the performance of the equipment, systems, controls, or process to be validated. It is approved by the quality assurance, validation, production, and engineering groups. 

After the qualification testing, a summary report should be written to summarize validation activities with a conclusion as to whether the instrument is suitable to be put into routine use. The report should highlight the objective and scope of the validation project, all the qualification test results, test exceptions, and a recommendation for system acceptance. All the test procedures, test results, and the summary report must be reviewed and approved by quality assurance and/or management before product use. 

Taylor, J. K. Quality Assurance of Chemical Measurements. Chelsea, MI Lewis Publishers, 1987. (Excellent summary of principles and extensive bibliography)... 

Audit Report. A report of an independent audit of the computer validation process by an internal auditor (i.e. Quality Assurance) should be included with the summary report to management. The audit should compare the SOP and the initial parts of the protocol (what the system should do) with the test plan results (what the system actually does) and the summary report conclusions. 

The audit was divided into two parts (1) General QA Practices and (2) Data Audit. A questionnaire as used by EPA s Office of Pesticide Programs, Quality Assurance Office, for Internal Audits, was employed. A copy of the completed questionnaire is(not) attached. From discussions, based on the questionnaire and observations made during inspection of the facilities and from a data audit, a subjective summary regarding... 

The approved summary report and associated validation documentation are submitted for retention to the National Quality Assurance Document Control Center or site documentation retention center... 

In addition, Quality Assurance records, summaries of training received, and job descriptions must be kept in permanent storage. 

This FDA Orphan-Drug Review checklist has been designed in consultation with FDA reviewers, industry consultants, and regulatory professionals to serve as a summary tool indicating the evaluative criteria used by the Office of Orphan-Drug Development to critique and assess applications received. It can be used internally as a part of the Quality Assurance process, as a guideline for regulatory development of an application, and/or as a self-assessment tool to predict likely FDA response to an application. 

In summary, and at the risk of repetition, it must be stressed that the development of analytical methodology for the assessment of human exposure to pesticides is a complex process. Careful attention to planning of the research is of utmost importance. As much information as possible about transformation, storage and excretion of the pesticides of interest should be gathered. Preliminary work should focus on the analytical behavior of parent compounds and metabolites. The combination of these aspects with reliable analytical standards and a sound quality assurance program should yield valid analytical methodology. 

Examples of quality assurance protocols that are considered standard practice in any data collection scheme include the use of both internal control samples (e.g. use of field blanks and spikes6) and external quality assurance samples (e.g. duplicate samples of known concentrations sent to different laboratories) to determine the extent of intra- and interlaboratory variation. Ensuring that the data have not been compromised or corrupted may also require setting up accessible data archives of original paper or electronic records so that the accuracy of summaries of the data published in documents and articles can be verified. 

If the integrated summary is based upon unaudited draft reports, sponsors should submit an update to their integrated summary by 120 days after the start of the human studies identifying any differences found in the preparation of the final, fully quality-assured study reports and the information submitted in the initial integrated summary. If no differences were found, that should be stated in the integrated summary update. In addition, any new finding discovered during the preparation of the final, fully quality-assured individual study reports that could affect subject safety must be reported to the FDA as an IND safety report. 

In summary, quality concrete can be produced if adequate quality control and quality assurance are exercised in all stages of its production and in the se-... 

Other documentation targeted for storage in archives include the master schedule sheet, copies of protocols, and records of quality assurance inspections, summaries of training and experience, job descriptions, records and reports of the maintenance and calibration and inspection of equipment. In any case, ensure that the protocol or SOPs address the proper archiving of appropriate materials. 

Module V Includes individual center summary reports, quality assurance measures, statistical methods and analyses and randomization lists. 

ASPH report. Summary of the final report of the ASPH 48. quality assurance indicators development group. Am. J. 

Table 3 Summary of various tests used in friction material manufacturing for raw material and finished product quality assurance...

In summary, four pillars support the structure of Good Laboratory Practice. All of them serve important functions in the context of performing and monitoring safety studies, and all of them need to be based on the strong conviction that GLP is the one mean to achieve quality data. Certainly, there are other aspects and issues in GLP that may be seen as nearly equally important, and they will be dealt with extensively further on, but Test Facility Management, Quality Assurance, Study Director, and National Compliance Monitoring Authorities are the key positions where real adherence to the Principles of GLP, not only by the letter but by the spirit of them, is determined in the end. 

In summary, while a study has to fulfil certain requirements, such as the presence of a study plan approved by dated signature of the Study Director before the start of the study, and while it has to undergo some control through inspections by the Quality Assurance, there may be instances where certain of these requirements would become nearly impossible to be fulfilled. Where a study is, however, of so short experimental duration, that it would be practically impossible to schedule the respective inspections, and where the administrative workload would become much higher than the workload for the actual conduct of the study itself, then, GLP would by right be considered a burden only. Therefore the requirements of GLP are adapted by the Principles to short-term studies in a way that allows for a certain alleviation of the workload for Study Directors, study personnel, and Quality Assurance. 

In summary, it will be the specialist, who will determine the end of usefulness of any sample or specimen, but it will also be the Quality Assurance who, through inspection and verification, will have to acknowledge the GLP compliance of the disposal procedures in general, and of the single processes and instances of discarding study-related material in particular. 

These final reports should contain in the introduction any changes from those reported in the integrated summary. If there are no changes, that should be clearly stated at the beginning of the final fully quality-assured report. 

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