Quality control method development

After World War 11, Japanese industry looked to quality-control methods developed in the United States to optimize the manufacturing process and improve products. The Japanese adoption of the methods was so successful that Made in Japan became synonymous with quality. 

The application of chemometrics to these problems includes three segments analytical quality control method and data base development and modeling Aroclor composition and PCB residues in bird eggs. 

Expert systems, however, have their disadvantages. Perhaps the most significant one is that it is hard to prove rigorously that they will not give an unexpected behavior. This causes production and quality control organizations to be reluctant to adapt to the methods. Writing a specification for expert system control is less exact and, therefore, more difficult to adapt to quality control methods that were developed for time-temperature-based plans. The... 

Near-infrared spectroscopy was proposed as an alternative to several compendial test methods. As an example, ampicillin trihydrate was used to demonstrate that in total, eight quality criteria could be checked and its conformity index calculated.Additional che-mometrics for quality control were developed by the same group. Their strategy was used to distinguish differences in mean particle size of various lactose samples and to study the effectiveness of a blending process for homogenous mixture preparation. 

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. ... 

Although BF provides a direct SSA measurement, the techniques of PSD, MIP and gas adsorption provide complementary information on texture characteristics to better understand and interpret results from process and formulation development studies. However, in some cases, BF can be considered as a complete and adequate quality control method which can easily be set to work within the frame work of production control provided that the method has been validated and applies well to the powder studied... 

The identity and quality of herbal material, herbal preparations and of finished herbal products should be tested as described in the Quality control methods for medicinal plant materials (d). The minimum requirement for the technical equipment is for instruments to perform the tests described in (d). Moreover, each country should develop this basic requirement for technical equipment further, according to the country s needs. 

The development and execution of quality control methods for herbal materials, herbal preparations and the finished herbal products should be in line with subsection 15.1 (Specifications). Tests and quality requirements that are characteristic of the given analyte should be selected. 

Develop and validate quality control methods for sterilization. 

The scientific goal of Working Group 1 (a) has been the development and updating of quality control methods to assure safety of Tc pharmaceuticals for parenteral application in nuclear medicine. Scientific institutions in 12 European countries have contributed their experience and results for comparison of the available methods. The Eu-... 

Willems, A.V., et al.. Development of a quality control method for the characterization of oligonucleotides by capillary zone electrophoresis-electrospray ionization-quadrupole time of flight-mass ctmva try. Electrophoresis, 26, 1412, 2005. 

There is no generally-acknowledged method or measuring unit to specify the extrusion behaviour of ceramic bodies. In order to obtain an adequately precise description of the extrusion behaviour, numerous specific methods do exist, which have to be chosen according to the material, for example for bodies to produce bricks and tiles or bodies for the manufacture of catalyst converters, as well as methods relating to specific application requirements, be it for example for the purposes of production, quality control or development of the body. 

The acidity of benzene, toluene, xylenes, naphthas, and other aromatic hydrocarbons is determined by the titration of a water extract with 0.01 N sodium hydroxide in the presence of 0.5% phenolphthalein indicator solution. The method is suitable for setting specifications, internal quality control, and development of solvents. The result indicates the potential corrosivity of solvent. 

Since 1924, when Shewhart first released his work adapting the scientific method to quality control, the development of quality management practices has been driven by increased application of the scientific method. The scientific method is shown in Figure 5.3 as the Theory-Hypotheses-Data-Verification cycle. Simply stated, the scientific method says that theories must be stated in a way that hypotheses can be formulated which can prove the theory wrong. A hypothesis is proved wrong by obtaining data. This data is analyzed (usually using... 

The performance of a method is expressed in terms of its specificity, sensitivity, accuracy, precision, detection and quantification limits, linearity, range, robustness, and ruggedness. In addition to the parameters listed above, other factors to be considered are simplicity and cost. The latter may be of less importance for methods used at the product development stage or for regulatory analysis but may be of considerable importance for routine quality control methods. 

The Vicat softening temperature (VST) is standardized in ISO 306 and ASTM D 1525. It is very useful as a quality control or development tool (ASTM D1525-2009). (This test method is technically equivalent to ISO 306 1987(E)). The result is a measure of the temperature at which thermoplastics begin to rapidly soften. VST describes the temperature at which a circular indenter with a cross section of 1 mm under a standardized loading of 10 N or 50 N penetrates exactly 1 mm into the specimen. VST was introduced to measurement technology as a substitute value for melting point. VST for some common polymers are presented in Table 10.20. 

If a laboratory is to produce analytical results of a quality that is acceptable to its clients, and allow it to perform well in proficiency tests or collaborative trials (see below), it is obviously essential that the results obtained in that laboratory should show excellent consistency from day to day. Checking for such consistency is complicated by the occurrence of random errors, so several statistical techniques have been developed to show whether or not time-dependent trends are occurring in the results, alongside these inevitable random errors. These are referred to as quality control methods. 

This book deals almost exclusively with studying polymers, by far the widest application of thermal analysis. In this area, TA is used not only for measuring the actual physical properties of materials but also for clarifying their thermal and mechanical histories, for characterizing and designing processes used in their manufacture, and for estimating their lifetimes in various environments. For these reasons, thermal analysis instruments are routinely used in laboratories of the plastics industry and other industries where polymers and plastics are being manufactured or developed. Thus, thermal analysis is one of the most important research and quality control methods in the development and manufacture of polymeric materials as well as in industries that incorporate these materials into their products. 

In order that reproducible results can be obtained from botanicals in research studies, all investigators should practice good quality control methods both in the selection of the source of botanicals and in the experimental design of their experiments. In a development that began in 2005, investigators seeking fimding from the National Center for Complementary and Alternative Medicine (NCCAM), a part of the NIH, are required to provide answers to... 

European Standards are published by the CEN European Committee for Standardization (www.cenorm.be). Standards are available covering performance specification, quality control, methods of test, methods of use and surface preparation. Originally developed as national standards, the needs of the single market, globalisation, and international trade have resulted in a gradual alignment with European Standards (EN) and ISO standards. Whenever a CEN... 

Frequently, a master chromatogram representing the acceptable range of GPC profiles is established with samples from good batches. All subsequent batches are then chromatographed and compared with the master curve as a rapid quality control method. Figure 7-14 illustrates the process. A number of correlations between the GPC curve and the physical and processing behaviors of a polymer have been developed. 

Quality control methods. Appropriate quality assurance tests need to be developed for evaluating the performance of the newer treatment techniques. 

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