Quality control protocol importance

While methods validation and accuracy testing considerations presented here have been frequently discussed in the literature, they have been included here to emphasize their importance in the design of a total quality control protocol. The Youden two sample quality control scheme has been adapted for continuous analytical performance surveillance. Methods for graphical display of systematic and random error patterns have been presented with simulated performance data. Daily examination of the T, D, and Q quality control plots may be used to assess analytical performance. Once identified, patterns in the quality control plots can be used to assist in the diagnosis of a problem. Patterns of behavior in the systematic error contribution are more frequent and easy to diagnose. However, pattern complications in both error domains are observed and simultaneous events in both T and D plots can help to isolate the problems. Point-by-point comparisons of T and D plots should be made daily (immediately after the data are generated). Early detection of abnormal behavior reduces the possibility that large numbers of samples will require reanalysis. 

Quality control encompasses all activities used to bring a system into statistical control. The most important facet of quality control is written documentation, including statements of good laboratory practices, good measurement practices, standard operating procedures, and protocols for a specific purpose. 

The endpoint measurement of the ideal test system must be objective, so that a given compound will give similar results when tested using the standard test protocol in different laboratories. If it is not possible to obtain reproductive results in a given laboratory over time or between various laboratories, then the historical database against which new compounds are evaluated will be time- and laboratory-dependent. Along these lines, it is important for the test protocol to incorporate internal standards to serve as quality controls. Thus, test data could be represented utilizing a reference scale based on the test system response to the internal controls. Such normalization, if properly documented, could reduce intertest variability. 

Traditionally, the education that chemists and chemistry laboratory technicians receive in colleges and universities does not prepare them adequately for some important aspects of the real world of work in their chosen field. Today s industrial laboratory analyst is deeply involved with such job issues as quality control, quality assurance, ISO 9000, standard operating procedures, calibration, standard reference materials, statistical control, control charts, proficiency testing, validation, system suitability, chain of custody, good laboratory practices, protocol, and audits. Yet, most of these terms are foreign to the college graduate and the new employee. 

No adjuvant is licensed as a medicinal product in its own right, but only as a component of a particular vaccine. Therefore preclinical and toxicology studies need to be designed on a case-by-case basis to evaluate the safety profile of the adjuvant and adjuvant/ vaccine combination [60], Evaluation in preclinical studies is important for identifying the optimum composition and formulation process and also for allowing development of tests for quality control [61]. Data from these studies also helps plan protocols for subsequent clinical trials from which safety and efficacy in humans can be evaluated. 

When preparing a method comparison study, the analytical methods to be studied should be established in the laboratory according to written protocols and stable in routine performance. Reagents are commonly supplied as ready-made analytical kits, perhaps implemented on a dedicated analytical instrument open or closed system). The technologists performing the study should be trained in the procedures and associated instrumentation. Further, it is important that an internal quality control system is in place to ensure that the methods being compared are running in the in-control state. 

One of the most important means of quality control of a clinical study is managed by frequent and thorough monitoring. A monitor s aim is first to protect the agenda of the sponsor/CRO who employs him/her. Monitors (often referred to as CRAs or Clinical Research Associates or Assistants in the pharmaceutical industry) must ensure maintenance of proper standards, compliance with the protocol, accurate and complete data capture and standardization across sites in a multicenter study. Basically, monitors will undertake the review noted in Table 12.8. 

An important aspect of trace analysis is that rigorous quality control must be included in analytical protocols if the results are to withstand international scrutiny. In cases of allegations of CW use, a chain of custody must be maintained and any positive analysis must be preceded by... 

Evaluation of the dissolution rates of drug substances from their dosage forms is extremely important in the development, formulation, and quality control of pharmaceutical agents [9,63-65]. Such evaluation is especially important in the characterization of polymorphic systems owing to the possibility of bioavailability differences that may arise from differences in dissolution rate that may themselves arise from differences in solubility [4]. The wide variety of methods for determining the dissolution rates of solids may be categorized either as batch methods or as continuous flow methods, for which detailed experimental protocols have been provided [66]. 

Small-scale spills of hazardous chemicals can occur in laboratories in educational institutions, quality control and testing laboratories, hospitals, greenhouses, and wherever small quantities of hazardous chemicals are handled. Such spills have less potential to cause widespread problems than spills on an industrial scale. However, they pose a risk to the health of workers in the laboratory or at the site of the spill from the inhalation of fumes, from the potential hazards of reactive chemicals, and, in the case of liquids, from slipping on wet floors. It is recognized that small spills should be cleaned up as quickly, responsibly, and efficiently as possible. Workplaces must have a protocol for handling spills and provide spill kits in appropriate locations. It is important that such kits be readily available in locations where they are easily accessed when needed. Furthermore, a plan needs to be in place to guide what is to be done with the residues from cleanup of the spills (National Research Council, 1995). 

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