Process Validation

CRITICAL PARAMETERS IN COATING OPERATION

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Following are the critical parameters in Coating operation Gun Geometry and Calibration Gun geometry and Calibration refers to the position of spray guns which includes ‘Gun Calibration’, ‘Gun to bed distance’, ‘Gun to gun distance’, ‘Gun to side of pan’, ‘choked guns’ and ‘anti bearing technology’. Gun to bed distance: Gun to Bed Height: Gun … Read more

UNDERSTANDING PROCESS VALIDATION APPROACH IN PHARMACEUTICAL INDUSTRY

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PROCESS VALIDATION Process validation is defined as the collection and evaluation of data from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Process validation involves a series of activities taking place over the lifecycle of the product and process. This guidance describes … Read more