Quality control laboratories, needs

Automation needs vary from laboratory to laboratory. Quality control laboratories might emphasize user simplicity and high throughput, while research laboratories might stress flexibility. 

Analytical methods used to determine purity and potency of an experimental API that is very early in development will need a less rigorous method validation exercise than would be required for a quality control laboratory method at the manufacturing site. An early phase project may have only a limited number of lots to be tested and the testing may be performed in only one laboratory by a limited number of analysts. The ability of the laboratory to control the method and its use is relatively high, particularly if laboratory leadership is clear in its expectations for the performance of the work. 

The environment in which a method is used changes significantly when the method is transferred to a quality control laboratory at the manufacturing site. The method may be replicated in several laboratories, multiple analysts may use it, and the method may be one of many methods used in the laboratory daily. The developing laboratory must therefore be aware of the needs of the receiving... 

Different emphasis may be used when justifying a new piece of instrument for use in a quality control laboratory as compared to an R D laboratory. In a qualify control environment, the justification is based primarily on the need and also on the return on investment. For R D laboratories, the capability enhancement potential of the new instrument is also a major consideration. The investment in new R D instruments may not have an immediate return. 

Number of Locations to Be Serviced. In the simplest case, there is only one location and that is all there is ever going to be. But just as often, there are two or more laboratories that might use a system profitably or have a need to coordinate with one another. A quality control laboratory, for example, might need to communicate with or use the same techniques and hardware as the methods development laboratory. The benefits of a system that services the needs of both laboratories and allows them to communicate are obvious. 

But there are signs that simpler, less expensive LC/MS systems designed and priced for the general laboratory bench chemist, production facilities, and quality control laboratories may soon be possible. It remains to seen whether manufacturers will decide to produce these systems. Older MS systems have been purchased, attached to HPLC systems equipped with relatively inexpensive interfaces, and pressed into service for molecular weight determination as a 30,000 detector, indicating that the desire and need exists for general laboratory LC/MS systems. As prices continue to drop and technology advances work their way out of the research laboratories, the LC/MS will become a major tool for the forensic chemist whose separations must stand up in court, for the clinical chemist whose separations impact life and death, and for the food and environmental chemist whose efforts affect the food we eat, the water we drink, and the air we breathe. 

Finally, the same questions should be asked in a critical manner of the in-process and final acceptance tests for raw materials, in-process intermediates, and final product. Imported and research tests often do not make good quality control laboratory tests. The quality control tests need to be robust, meaningful, validated, and reproducible. Many research assays are narrow in scope, unstable, user-dependent, and complex, and they also yield wide-ranging results. These assay characteristics are exactly the opposite of what is needed in quality control therefore, all analytical methods and assays must be critically evaluated for relevance and validated for use. 

Because of their increasing use worldwide, plant materials used in over-the-counter preparations, home remedies, or as raw materials for pharmaceutical preparations are receiving more and more attention. In 1998, WHO published a book. Quality Control Methods for Medicinal Plant Materials to fulfill the needs of quality control laboratories and to provide a basis for the development of national standards. ... 

Quality Assurance and Quality Control. The terms "quality assurance"(QA) and "quality control"(QC) need to be defined. They are often used interchangeably, but to the professional they refer to two different activities. Quality control refers to those actions taken in the laboratory in an attempt to keep the measurement system in control. Examples would be running reference standards, calibrating Instruments, keeping quality control charts, etc. Quality assurance refers to the system or program whereby management assures itself (and its clients) that the quality control measures are being applied, and that the results reported do, in fact, refer to the sample that was submitted or collected by the laboratory. 

To safeguard against such a situation arising, a first step can be taken after a grade of carbon has been tentatively selected for purchase. For this, a laboratory study is conducted in which the process liquor is treated with different batches of that grade of carbon this will disclose whether special quality controls are needed to ensure trouble-free shipments. 

The situation Is much the same in most of industry, where quality control laboratories have become much more important than they used to be a few years ago. The demands in this area are dictated by the large number of samples to be analysed, the need to automate manufacturing processes requiring one-off determinations at some point along the production line and the quality now required of manufactured goods. It Is therefore necessary to control not only the raw materials, but also the Intermediate and end products. 

However, several problems still exist. These include sensor drift, which leads to the inability to provide proper calibration. This is of special concern to quality control laboratories and is one of the reasons for the general absence of these instruments in these laboratories [3]. Limitations to the use of the electronic nose include loss of sensitivity in the presence of water vapor and high concentrations of individual components such as alcohol, relatively short life of some sensors, and the inability to obtain quantitative data for aroma differences [72]. Each device also still needs considerable method development, but progress is being made at a rapid rate. Einally, sensor arrays and PR tend to predict the quality of a sample without providing hard data with respect to composition and concentration [74]. 

Front-end tools. Chemical reactors, in particular polymer reactors are multivariable, exhibit nonlinear characteristics, and often have significant time delays. In this case the operator cannot easily visualize what is happening in the process, so the computer should aid for visualization of the process state and its relation to the quality of the final product. As the final product quality is measured in the quality control laboratory, not only WYSIWYW (What you see is what you want) interfaces between the operator and the consol are important but WYSIWIS (What you see is what I see) interfaces between the operators (operators at the reactor, at the product formation process, and at the laboratory) are needed to share the information horizontally in the organization. 

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