Abstract: The purpose of research was to study prospective process validationfor Aceclofenac 100 mgand paracetemol 500mg tablets dosage formulation. 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 parameter involved in sifting, 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.
Keywords: Aceclofenac, Paracetamol, Prospective Process Validation, Validation.
Title: Process Validation for Aceclofenac 100mg and Paracetamol 500mg Tablets
Author: Shahin.Mohammad, K.Ayeshabegum, P.Sandhya
International Journal of Thesis Projects and Dissertations (IJTPD)
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