Process Validation of Sertraline Hydrochloride 50 mg tablets

Abstract

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