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The purpose of this effort is to provide an introduction and overview of the process validation of the production of pharmaceutical manufacturing process especially tablet with particular attention to the U.S. Food and Drug Administration requirements (FDA). Quality is always a prerequisite when looking at a product. Therefore, drugs must be manufactured to the highest quality standards. In the context of one of the types of process validation, retrospective validation are used for the facilities , processes and process controls in use that have not been subjected to a documented formal process validation (prospective, concurrent ) . The validation of these facilities , processes and process controls can use historical data to provide the necessary evidence that the process does what it is supposed to do provide the source of data for this study include , but are not limited to processing batch records and packing , process control charts , logs, maintenance records personnel changes , process capability studies , final data, including trend cards and storage stability validation results. Retrospective validation is the starting point for the non-regulated or Sami-regulated toward the compliance of cGMP and is less expensive exercise to evaluate and demonstrate the product quality. Application of statistical and quality control will give a strength, confidence and reliability to demonstrate the

Application of Quality Control and Statistical Tools to Demonstrate The Retrospective Process Validation