Scale up is generally defined as the process of increasing batch
size. In process scale up a formula is transformed into a viable,
robust product by the development of a reliable and practical
method of manufacturing that effect the orderly transition from
laboratory to routine processing in a full-scale production
facility. It must include a close examination of the formula to
determine its ability to withstand batch-scale and process
modification. So process scale up of Metformin HCL tablet includes
Trial Batches, Exhibit Batches and Validation Batch. After these
batches produce large scale up Metformin HCL Tablets. During the
scale up process controls are evaluated, valuated and finalized in
addition, appropriate records and report are issued to support good
manufacturing practices and to provide the historical development
of the production, formulation, process equipments train, and
specification.
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