Abstract
PRACTICAL APPLICATION OF QUALITY RISK MANAGEMENT TO CEFTRIAXONE SODIUM DRY POWDER INJECTION MANUFACTURING

Divyanginee Patel*, Rakesh Kaul, Trupti Davawala and Rukshar Shaikh

ABSTRACT

This article presents risk analysis performed on the Ceftriaxone sodium dry powder injections manufacturing process and the conclusion obtained from the analysis. The objective of this study was to assess and mitigate the risk at all stages before the manufacturing process initiated and to evaluate the current controls and decide the future actions to be taken for improvement of product/process reliability and quality of the product for commercial use. In addition, the aim of the present work is to illustrate the application of different risk management tools and the permeability of the local pharmaceutical industry to these ideas. Failure Mode and Effects Analysis (FMEA) method was used for evaluating a process to identify where and how it might fail and they were decided on the basis of the rankings given to the severity (S), occurrence (O) and detectability (D) based on the prior experience, regulatory requirements, customer complaints, analytical results of the product testing and knowledge. Failure risks were calculated by Risk Priority Number (RPNs). Failure modes with the highest RPN scores were subjected to corrective action. Results are predicted by RPN that the risk is acceptable, unacceptable or intolerable. According to RPN, the risk is categorized in low, medium and high. The RPN between 1-120 are low risk, RPN between 121-499 is medium and RPN above 500 is high risk. After corrective actions taken, the whole procedure was repeated and RPNs for this was calculated. The reduction in RPN was seen and so the reduction in risk was seen.

Keywords: RPN, Severity, Occurrence, Detectability, FMEA.


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