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The Lean Management had its origin in the 50s in the Japanese automobile industry, and is currently used in different production processes, included those related to pharmaceutical production, for which has raised its application in the manufacture of loperamide HCl-orodispersible tablets (HCl-ODT) under the coordination of the Pharmaceutical Quality System (PQS). A theoretical proposal for process reengineering has been carried out both incorporating and applying the different Lean tools in the industrial manufacturing process of HCl-ODT, and their subsequent integration into the PQS, through each one of the processes stages, such as: weighing, screening, mixing, compression, and packaging, under the compliance of the current legislation of the pharmaceutical industry and in compatibility with what is established in the ICHs within the Quality System, in order to increase the effectiveness and efficiency of the process and its profitability. Lean Management under the coordination of the Pharmaceutical Quality System (PQS), is an excellent strategy for manufacturing loperamide HCl-orodispersible tablets since it improves its Quality System, as well as facilitates compliance with the national and international guides, standards and legislation that are suitable to it.