QA/QC efforts

Definitive diagnosis comes at a cost. QA/QC expenses, regulatory expenses, and patent royalty expenses are high, as are supply costs for consumables, reagents, and test kits. Morever, the equipment required for assay and result delivery and accuracy can be expensive. In the sections that follow, an outline of how these costs are calculated is provided and an effort is made to flesh out a difficult area to quantify. Generally, test costs, neglecting administration and overhead, can be... 

On the one hand, as already experienced in case of the analytical classical methods in the past years, also in case of SMETs at European level there should be substantial efforts in providing resources to support their diffusion in routine laboratories, to disseminate the correct QA/QC culture for these methods and contemporarily to support RM producers to shape-cut technologies to satisfy the test sample needs of SMET. 

Upon satisfactory completion of the criteria, the drug is further assessed and nominated as a candidate for future development by a product selection committee for market introduction. The selection process is a team-effort, multiple-discipline decision. Members of the team represent a cross section of corporate functional organizations, such as research and development (R D), production, marketing, medical, and quality assurance/quality control (QA/QC) departments of the company. 

For a site activity under the purview of the Removal Program, the On-Scene Coordinator (OSC) has the responsibility of preparing the site-specific Sampling QA/QC Plan. The objective of the Sampling QA/QC Plan is to ensure that field sampling efforts and analytical services will provide data of known quality [The quality of data are known when all components associated with their derivation are 0097—6156/90/0431—0082 06.00/0 1990 American Chemical Society... 

Once implemented, method performance is monitored with ongoing QA/QC, as discussed in Chapter 10. If the method fails during validation, then further method development and revision is required prior to another attempt at validation. If at any time following validation and implementation, QA/QC reveals the method is not meeting performance standards, an investigation and identification of cause is required. Again, this may require method modification and re-validation. If a method consistently fails validation experiments despite best efforts to remedy the performance issues, then at some point a decision must be made that the method cannot be considered as likely to meet fit-for-purpose requirements and an alternative method should be sought. 

The results of QC sample analyses are evaluated with statistical tests (see Section 10.5) and presented in tandem with the sample batch results to which they correspond. Good QC results give confidence that the laboratory procedures and personnel operated satisfactorily for that batch. Bad QC results show the need for investigation and remeasurement. The QA officer keeps track of the laboratory s QC efforts, and the results are filed as specified by the QAP. 

The complexities involved in NDD have increased in the past 5 years. This has occurred as the result of enhanced drug development techniques and global registration attempts. Spurred also by the effort to maximize profits, this phenomenon has placed the Quality process under increased and manifold stress. The QA and QC processes are placed in the forefront by any major drug development organization. The efforts of QA will be reviewed in this chapter. 

Application of these measures to reduce the frequency of reanalysis required in the radioanalytical chemistry laboratory can be justified by a cost-benefit analysis. The general purpose of supporting acceptance of analytical results has a less determinate economic benefit. The time and effort devoted to QA has increased from about 10% of the total analytical workload to 25-30% at present, as regulatory agencies have required more quality control (QC) measurements and more supporting documents. This increasing cost includes QC measurements, organization and actions instituted to ensure correct and defensible data output. The costs and benefits of QA are considered in Section 11.4. 

A significant fraction of laboratory effort mnst be devoted to weeding out false results by consistent application of the QA techniques discussed in the earlier sections of this chapter, preferably before such results are reported. The QC program and interlaboratory comparisons are designed to identify systematic errors in chemical analysis and radiation measurement due to problematic methods or analysts. By chance, QC results instead may identify an occasional error due to lack of attention in analysis, measurement, recording, or calculation. More commonly, occasional errors are found during data review (see Section 10.6). 

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