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Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.
ÿIn Britain, most of us take electricity for granted. When there are power cuts, we are shocked by the gloom and the silence and how dependent on electricity we have become. Critics predicted that the privatisation of electricity supply in 1990 would lead to power shortages. Elsewhere in Europe it was sometimes dismissed contemptuously as ?The British Experiment?. But the plan worked. Private investment flowed and customers reaped the benefits. Then it began to go wrong. Governments wanted more and more say, but their policies were often confusing and sometimes merely vote-catching The confidence of investors was damaged. Power stations closed faster than they were replaced. The risk of pow...