The document discusses the qualification process for the tablet compression equipment. It describes the steps of design and style qualification, set up qualification, operational qualification, and effectiveness qualification. Structure qualification establishes that the equipment design satisfies specifications.Discover the FDA's critical part in
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The importance of extractables & leachables tests has developed with enhanced utilization of solitary-use systems. As a result, E&L testing can be a regulatory requirement to demonstrate that leachable impurities from plastic materials Employed in the processing of the health-related item don’t interfere Using the active pharmaceutical component,