ABSTRACT:
The rationale of the research investigation was to study prospective process validation of Fluconazole 150 mg tablet dosage form. Quality cannot be assured by in-process and finished product testing but it should be built in to the manufacturing process. The processes should be controlled so that the finished product meets all quality attribute specification. So building of quality requires careful attention to many factors, such as the selection of materials, design of product and process, control variables, in process control and finished product testing. The process parameters that are critical were identified with the help of process capability and evaluated by challenging its lower and upper release specifications. Three initial consecutive process validation batches of same batch size, method, and equipment and validation criteria were considered. The critical process parameter during stages like sifting, dry mixing, preparation of binding solution, wet mixing, wet milling, drying, sifting, lubrication and compression stages were recognized and evaluated as per validation plan. The outcome indicated that this process validation data provides high degree of assurance that manufacturing process produces product meeting its predetermined specifications and quality attributes.