Process Validation of Cefixime Powder for Suspension Dosage Form, 50 mL

Authors: Shome M* , Kundu SK , Alam MT , Bokshi B and Chowdhury K

DOI: 10.23880/nnoa-16000344

Volume 10, Issue 2

Abstract

The objective of this research investigation was to study the prospective process validation of Cefixime powder for oral suspension. Quality cannot be assured solely through in-process and finished product inspections and testing; rather, it must be integrated into the manufacturing process. To ensure that the finished product meets all quality specifications, these processes must be carefully controlled. Building quality into the product requires meticulous attention to several factors, including the selection of materials, product and process design, control of variables, in-process controls, and finished product testing. Critical process parameters were identified using process capability analysis and evaluated by challenging their lower and upper release specifications. Three initial process validation batches were conducted under consistent conditions, including batch size, methods, equipment, and validation criteria. Critical parameters were evaluated at multiple stages of the manufacturing process, including dispensing, sieving, dry mixing, filling, and sealing, in accordance with the validation protocol. A drying time of 120 minutes at 60°C was found to be appropriate for achieving a moisture content of crushed sugar within the specified limit of NMT 0.2%. The optimal mixing uniformity was achieved at 70 minutes at 8 RPM, as indicated by a relative standard deviation (RSD) ranging from 1.29% to 2.33%, well within the acceptance criterion of NMT 5.0%. The results obtained from all three validation batches at each stage of manufacturing confirmed compliance with the acceptable range of 90% to 110%. Furthermore, the active content in the reconstituted liquid suspension remained within the acceptable range of 90% to 110% on both Day 1 and Day 7, ensuring stability over the intended period. These findings confirm that the process validation data from three consecutive batches provides a high degree of assurance that the manufacturing process for Cefixime powder for oral suspension consistently produces a product that meets predetermined specifications and quality standards.

Keywords: Prospective Process Validation; Control Variables; In-Process Control

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