PROCESS DEVELOPMENT, OPTIMIZATION AND VALIDATION OF MANUFACTURING PROCESS OF ALLOPURINOL
Keywords:Allopurinol, Specification, Validation, Critical process parameters, Operating range, Robustness
Objective: The objective of the present research work is to identify the critical parameters in the process that affect the quality of the finished product. The processs validation of the manufacturing process for Allopurinol tablet USP, 300 mg to be manufactured with change in manufacturing site and with increased batch size.
Methods: Prior to Scaling up to production, pilot batches were manufactured. Three consecutive commercial batches are to be produced using similar test equipment and in full compliance with cGMP and existing SOPs. Critical process parameters of the machine was set within operating range and was not exceeded upper and lower control limits during process operation. Equipment were operated within its assigned control limits, which shows upon scale up into new site, the specification for hardness did not meet requirements that had been set during development. There was no significant effect observed on thickness, friability, disintegration, dissolution, uniformity of dosage and were found within specification. Pre process batch was challenged by manufacturing product at upper and lower processing limits and circumstances which pose the greatest chance of process or product failure compared to ideal condition.
Results: Based on the data obtained from pre-process validation batch, operating ranges for compression force and machine speed had been established. Collected data shows robustness around these parameters and there is increased confidence that the process can be successfully scaled up under target conditions for these parameters.
Conclusion: From this study, it was concluded that process was optimized and gave a reproducible product that meet predetermined quality requirements and do so consistently and reliably.
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