Reliability quality assurance

Generic policies are effective instruments when a patent expires. In the United States of America the average whole sale price falls to 60% of the price of the branded medicines when one generic competitor enters the market, and to 29% when 10 competitors. To introduce and expand the use of generic medicine products, it is important that (1) supportive regulations exist, (2) reliable quality assurance is in place. 

Cohen B., Improving Analog CT Image Quality , 1991, Research Thesis, Doctor of Science, The Department of Quality Assurance and Reliability,. Technion. 

Nelson, D. L. 1996 Supplier Reliability and Quality Assurance. In Ireson, W. G., Coombs, C. F. and Moss, R. Y. (eds). Handbook of Reliability Engineering and Management, 2nd Edition. NY McGraw-Hill. 

Quality-assurance procedures have to be established for the checking of both input and results checks of energy balances, plausibility tests, and comparison with steady-state calculations and with results from similar cases. These checks are demanding and time consuming and thus prone to be omitted but are mandatory for reliable simulations. 

The final element which regulations address is quality. Safety and fitness for purpose, as discussed above, are two of the characteristics that you would associate with a quality product. However, these characteristics alone would not describe a quality product. For any product or service to be considered quality you would also expect it to be reliable and consistent. Additionally in the context of medical products, quality means a requirement to demonstrate conformance to agreed specifications or applicable standards for content, purity and stability. Many organisations, from manufacturers to service providers, voluntarily apply quality assurance systems in order to more effectively meet their customers needs on a consistent basis. However,... 

Monitoring programs must have their own quality assurance programs. These may be called project quality assurance plans or protocols for specific purposes O). If reliable vendors of services are used, the bulk of the quality assurance effort can be placed on those activities unique to the program. Without reliable vendors, QA efforts will be ineffective since it is not cost effective to police quality assurance practices at all lower levels nor to screen all data for its validity. 

Since the early 1970 s there has been a growing belief that chemical measurements must not only be done correctly, but that data, the product of the measurement process, must be seen to be accurate, precise, and reliable. Analytical data have become another manufactured product and like all manufactured products, the customers demand that Quality Assurance (QA) must be built in. 

Standards are being used in the context of Analytical Quality Assurance, which is the demonstration to the end-user that the delivered product, the measurement data, are reliable and have been made according to the best practices currently possible. Standards facilitate, some would say are essential to, living and trading in the global village. Standards have become standard in everyday life. 

Quality assurance is the part of quality management focused on providing confidence that quality requirements will be fulfilled. It is all the planned and systematic activities implemented within the quality system, and demonstrated as needed, to provide adequate confidence that the analytical service will fulfil the requirements for quality. Quality assurance is the essential organizational infrastructure that supports all reliable analytical measurements. It encompasses... 

The previous chapters of this book have discussed the many activities which laboratories undertake to help ensure the quality of the analytical results that are produced. There are many aspects of quality assurance and quality control that analysts carry out on a day-to-day basis to help them produce reliable results. Control charts are used to monitor method performance and identify when problems have arisen, and Certified Reference Materials are used to evaluate any bias in the results produced. These activities are sometimes referred to as internal quality control (IQC). In addition to all of these activities, it is extremely useful for laboratories to obtain an independent check of their performance and to be able to compare their performance with that of other laboratories carrying out similar types of analyses. This is achieved by taking part in interlaboratory studies. There are two main types of interlaboratory studies, namely proficiency testing (PT) schemes and collaborative studies (also known as collaborative trials). 

The management of an analytical chemistry laboratory involves a number of different but related operations. Analysts will be concerned with the development and routine application of analytical methods under optimum conditions. Instruments have to be set up to operate efficiently, reproducibly and reliably, sometimes over long periods and for a variety of analyses. Results will need to be recorded and presented so that the maximum information may be extracted from them. Repetitive analysis under identical conditions is often required, for instance, in quality assurance programmes. Hence a large number of results will need to be collated and interpreted so that conclusions may be drawn from their overall pattern. The progress of samples through a laboratory needs to be logged and results presented, stored, transmitted and retrieved in an ordered manner. Computers and microprocessors can contribute to these operations in a variety of ways. 

The Chem Master Workstation is a gas chromatography and gas chromatography-mass spectrometry data-processing system that speeds the flow of data through the laboratory and provides essential quality-assurance and quality-control review. It is a PC-based integrated hardware/ software system that converts gas chromatographic and gas chromatography-mass spectrometric data into reliable analytical reports. 

Stability of calibrants and analytes is another frequently overlooked aspect of quality assurance, which is particularly relevant to surfactants. This aspect is discussed in Chapter 4.4. Very few intercalibration studies have been performed for the surfactant types of analytes (cf. Chapter 4.5). Currently, no certified reference material is available for surfactants. The European Commission has recently tendered for production of a reference material with certified surfactant concentrations [2]. We can conclude that quality assurance in quantitative surfactant analysis is still in its infancy when compared to analysis of PCB or chlorinated dioxins. Notwithstanding this, several important achievements have been made during recent years regarding improvement of the accuracy and reliability of qualitative analysis of surfactants, which will be the subject of the following chapters. 

The FSA undertakes surveillance exercises, the data for which are acquired from analytical determinations. The Agency will take measures to ensure that the analytical data produced by contractors are sufficient with respect to analytical quality, i.e. that the results obtained meet predetermined analytical quality requirements such as fitness-for-purpose, accuracy and reliability. Thus when inviting tenders FSA will ask potential contractors to provide information regarding the performance requirements of the methods to be used in the exercise, e.g. limit of detection, accuracy, precision etc., and the quality assurance measures used in their laboratories. When presenting tenders, laboratories should confirm how they comply with these specifications and give the principles of the methods to be used. These requirements extend both to the laboratory as a whole and to the specific analytical determinations being required in the surveillance exercise. The requirements are described in three parts, namely ... 

Performing a thorough method validation can be a tedious process, but the reliability of the data generated with the method is linked directly to the application of quality assurance and quality control protocols, which must be followed assiduously (Table 6.5). 

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