Mohamad Hajimolaali and Akbar Abdollahi Asl
Objectives: Quality risk assessment is one of the most important components of the quality assurance division in pharmaceutical industry. To the best of our knowledge there is no previous study assessing risks and disruptions of the quality risk assessment in beta-lactam production in pharmaceutical companies. The lack o risk assessment may due to disrupt quality system, safety and efficiency of the product. The aim of this study was to evaluate the risk assessment in beta-lactam production in Iran considering process’s priority, hazard and probability, severity and detectability of risks.
Methods: The study was carried out in 3 phases; risk identification through literature review, risk identification in Iranian pharmaceutical companies through interview with experts, risk analysis through a questionnaire and consultation with experts using group analytic hierarchy process Failure Mode Effects Analysis (FMEA) method and priority and risk evaluation of Fuzzy method in five Iranian pharmaceutical companies.
Results: According to the results, 109 main risks were identified in these pharmaceutical companies which could be divided in seven categories. The majority finding of the risks in this study were related to the quality control, quality assurance and manufacturing process. The manufacturing process and quality assurance were found to be the most important factor for consideration.
Conclusion: The results of the present study suggested that the FMEA method in conjunction with the supporting fuzzy set method can be effectively used for risk assessment in beta-lactam production and pharmaceutical industry. In this course, the risk assessment is the goal of this research. The use of this approach can support the project management team to establish corrective actions in quality system.
In future, we suppose to develop methods and strategy for the integration of different information Technologies and methods of analysis (FMEA). Also we will hope to reduction the risks, and Management stated strategy in companies.
