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Divyanginee Patel*, Rakesh Kaul and Ankita Bhavsar


The objective of this study was to assess and mitigate the risk at all stages before the manufacturing process of Ceftriaxone sodium (CFTX) dry powder injection was initiated. To evaluate the current controls and decide the future actions to be taken for the improvement of product/process reliability and quality of the product for commercial use of early identification and elimination of potential product/process failure modes. The method used was Failure Mode Effect Analysis (FMEA). It is a systematic, proactive method for evaluating a process to identify where and how it might fail and to assess the relative impact of different failures, in order to identify the parts of the process that are most in need of change. Subjected a sterile dry powder injection to a failure mode effect analysis, including technical risks as well as risks related to human failure, which break down the formulation into the process steps and identified possible failure modes for each step, each failure mode was ranked on the estimated frequency of occurrence, detectability and severity. Failure risks were calculated by Risk Priority Number (RPN). Results were predicted by a risk priority number that the risk is acceptable, unacceptable or intolerable. According to the results, corrective actions are taken.This article describes practical ways to analyze the risks to the quality system, providing the way to achieving effective and efficient quality management and compliance. Risk management improves decision making if a quality problem arises.

Keywords: FMEA, dry powder injection, risk assessment, RPN.

[Full Text Article]

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