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The qualification process for ensuring that a paddle or basket apparatus is suitable for its intended use is a highly debated and controversial topic. Different instrument qualification and suitability methods have been proposed by the pharmacopeias and regulatory bodies. In an effort to internationally harmonize dissolution apparatus suitability requirements, the International Pharmaceutical Federation's...
Purpose USP has formed Advisory Panels to ensure the integrity of laboratory procedures for non-oral routes of administration and expects that the panels will recommend performance tests (performance qualification, PQ) for these dosage forms as well as performance verification tests (PVT) for those PQ tests. An integral part of PQ is PVT, in which a standard formulation is first tested in a metrologically...
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