Triamcinolone Acetonide Acetate Injection Production Line Engineering Design Research Of Risk Management

The pharmaceutical industry as an industry is directly related to people’s life, providing health care for patients at the same time, bear the risk. In recent years the adr happened frequently, especially the injection is directly related to the life safety of patients, its product quality must be guaranteed.As countries to strengthen drug regulatory and promotion enterprise’s quality consciousness, the pharmaceutical companies to avoid risk, to provide patients with safe and reliable products, it must start from the source of production. This paper, taking triamcinolone acetonide acetate injection production line engineering design process of the risk control as the research object, in project risk management theory as the tool. First of all, the triamcinolone acetonide acetate injection production line engineering design and construction project risk analysis. From the production line of HVAC system, plant, and compressed air system, water system, personnel, equipment and so on six aspects, qualitative and quantitative analysis. Through a review of the results, the risk is divided into high risk level, medium level of risk, low risk level.And then, on the basis of risk evaluation, of triamcinolone acetonide acetate injection production line of HVAC system, plant, and compressed air system, water system, personnel, equipment and so on six aspects of risk issues were studied. Suggested that in the process of construction of production line design is introduced into the potential failure mode and effects analysis (FMEA) "tools for risk identification, analysis, evaluation, and puts forward concrete measures to control the risks, through confirmed after the completion of production line, to effectively control the potential risks.Hope in this paper, the risk management and from the workshop design began to control the quality of the final product concept of "quality is the result of design (QbD)" in pharmaceutical enterprise promotion, implementation and play a positive role as a reference.