The purpose of present research work was to study process validation for Nifedipine Sustained Release 20mg Coated Tablet dosage formulation. In pharmaceutical organizations, validation is a fundamental segment that supports company commitment to quality assurance. Quality cannot be adequately assured by in-process and finished inspections and testing but it should be built in to the manufacturing process. These processes should be controlled in order that the finished product meets all quality specifications.The critical process parameters were identified with the help of process capability and evaluated by challenging its lower & upper release specification. Three initial process validation batches (I, II & III) of same size, method, equipment & validation criteria was taken. The critical parameters involved in sifting,milling, dry mixing, preparation of granulating agent, wet mixing, wet milling, drying, sizing, lubrication, compression stages & coating were identified and evaluated as per validation master 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.
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