Abstract

STUDIES IN PROSPECTIVE PROCESS VALIDATION OF RANITIDINE AND ONDANSETRON COMBINATION INJECTION DOSAGE FORM

Vaibhav R. Mandale*, Archana M. Karnik, Atul S. Sayare, Avinash R. Tekade, Ashlesha P. Pandit and Sneha A. Kasbe

Abstract

The purpose of the research investigation was to study prospective process validation of Ondansetron 2 mg/mL, Ranitidine 25 mg/mL, Injection USP, 2ml, Single Dose Vial. 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. Therefore building of quality requires careful attention to a number of factors, such as the selection of materials, product and process design, control variables, in process control and finished product testing. The critical process parameters were identified with the help of process capability and evaluated by challenging its lower and upper release specifications. Three initial process validation batches of same size, method, equipment & validation criteria were taken. The critical parameter involved in addition of water for injection, mixing, filtration, filling, sealing, leak testing, visual inspection & packing stages were identified 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. From the review of data recorded during manufacturing process, in process testing and finished product analysis of all the three validation batches, it is concluded that the manufacturing process is consistent and meets the pre-determined specifications and quality attributes. Hence the manufacturing process of Ondansetron 2 mg/mL, Ranitidine 25 mg/mL, Injection USP, 2ml, Single Dose Vial, stands validated.

Keywords: Prospective Process validation, Control variables, Ondansetron- Ranitidine Injection USP.