作者: Parixit Rohitbhai Prajapati , Deepika Natu Rathod , Vishalkumar Shashikant Modi , Tarasankar Basuri
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摘要: The purpose of present research work wasto study Process Validation Sertraline hydrochloride 50 mg tablet dosage form. As in a pharmaceutical product the quality cannot be directly incorporated or assured by process and finished products inspections testing rather it has to manufacturing itself. helps controlling all parameters so that meets specifications attributes. Various critical involved were identified with help capability thereby evaluating challenging its lower upper specifications. Three initial batches same size, method, equipment validation criteria chosen. Other sifting, dry mixing, wet granulation, drying, sifting sizing, lubrication, compression coating stages as per Master Plan. outcome was is providing provide high degree assurance producing meeting predetermined