风险管理在小容量注射剂生产质量管理中的应用探讨
发布时间：2018-12-15 22:51
【摘要】：药品作为特殊商品,其质量与患者的生命息息相关,随着社会的进步,人民群众生活水平的逐渐提高,对药品质量风险的认识也在逐步提高,在这种情况下,药品生产企业的首要任务是加强生产中各方面的控制,降低风险水平,保证药品质量。无菌制剂中的小容量注射剂,属于高风险剂型,生产过程复杂,风险控制点多,对硬件、软件、湿件都有着严格的要求,如何做到小容量注射剂的安全、有效、稳定、均一,杜绝药害事件的发生,降低生产过程中的各种风险至可接受水平,是无菌药品生产企业所面临的一个问题与挑战,也是一个值得持续不断改进的研究课题。 本文主要运用一些常用的风险管理工具对小容量注射剂车间从符合2010版GMP法规改造设计到生产过程质量控制进行风险评估,对生产过程中存在的风险进行识别、分析、评价,对不能接受的风险采取适当的措施进行控制,最终达到降低风险,保证产品质量的目的,本课题运用的风险管理工具有鱼骨图法、失效模式效果分析法(FMEA)和危害分析关键控制点法(HACCP),对车间硬件需要改造的厂房、设备、空调净化系统等方面运用该工具进行风险评估,确定改造方案,进行实施,通过2010版GMP认证。 依据我公司通过2010版GMP认证的小容量注射剂车间为例,确定小容量注射剂生产过程中产生的可见异物仍然是继续存在的风险,运用鱼骨图法找出导致风险产生的因素,进行分析研究,找出控制措施,进行实施,将可见异物风险降至最低。 通过风险管理在小容量注射剂生产车间符合2010版GMP改造中的应用,使我公司小容量注射剂车间顺利通过国家2010版GMP认证,然后在通过GMP认证车间的生产过程中持续应用风险管理理念找出风险点进行控制,使生产过程中的可见异物得到进一步控制。在小容量注射剂生产过程中持续不断地运用风险管理理念及工具对生产过程进行风险评估,制定风险控制措施,不断提高生产效率,保证产品质量。
[Abstract]:As a special commodity, the quality of drugs is closely related to the lives of patients. With the progress of society and the gradual improvement of people's living standards, the awareness of drug quality risks is also gradually improving. In this case, The primary task of pharmaceutical production enterprises is to strengthen the control of all aspects of production, reduce the level of risk, and ensure the quality of drugs. The small volume injection in aseptic preparation belongs to the high risk dosage form, the production process is complicated, the risk control point is many, has the strict request to the hardware, the software, the wet part, how to make the small volume injection safe, effective, stable, uniform, It is a problem and challenge for aseptic drug manufacturing enterprises to put an end to the occurrence of drug damage events and reduce the risks to acceptable level in the production process. It is also a research subject worthy of continuous improvement. This article mainly uses some commonly used risk management tools to carry on the risk assessment to the small capacity injection workshop from the transformation design according to the 2010 edition GMP law and regulations to the production process quality control, carries on the identification, the analysis, the appraisal to the production process risk, Take appropriate measures to control the unacceptable risk, and finally achieve the goal of reducing the risk and ensuring the quality of the product. The risk management tool used in this project is the fish bone map method. Failure Mode effect Analysis (FMEA) and Hazard Analysis critical Control Point (HACCP),) are used to evaluate the risk of workshop hardware, equipment, air conditioning purification system and so on. Through the 2010 version of GMP certification. According to the example of the small volume injection workshop certified by our company through version 2010 of GMP, it is determined that the visible foreign body produced during the production of small volume injection is still a continuing risk, and the factors leading to the risk are found by using the fish bone graph method. The risk of visible foreign bodies will be minimized by analyzing and studying, finding out the control measures and carrying out the implementation. Through the application of risk management in the transformation of 2010 GMP in the small volume injection production workshop, the small volume injection workshop of our company has been successfully certified by the national 2010 edition GMP. Then, risk management concept is continuously applied in the production process of GMP certification workshop to find out the risk points and control the visible foreign bodies in the production process. In the process of small volume injection production, risk management concepts and tools are continuously used to evaluate the risk of the production process, to formulate risk control measures, to continuously improve the production efficiency and to ensure the quality of the product.
【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R943
本文编号：2381412
[Abstract]:As a special commodity, the quality of drugs is closely related to the lives of patients. With the progress of society and the gradual improvement of people's living standards, the awareness of drug quality risks is also gradually improving. In this case, The primary task of pharmaceutical production enterprises is to strengthen the control of all aspects of production, reduce the level of risk, and ensure the quality of drugs. The small volume injection in aseptic preparation belongs to the high risk dosage form, the production process is complicated, the risk control point is many, has the strict request to the hardware, the software, the wet part, how to make the small volume injection safe, effective, stable, uniform, It is a problem and challenge for aseptic drug manufacturing enterprises to put an end to the occurrence of drug damage events and reduce the risks to acceptable level in the production process. It is also a research subject worthy of continuous improvement. This article mainly uses some commonly used risk management tools to carry on the risk assessment to the small capacity injection workshop from the transformation design according to the 2010 edition GMP law and regulations to the production process quality control, carries on the identification, the analysis, the appraisal to the production process risk, Take appropriate measures to control the unacceptable risk, and finally achieve the goal of reducing the risk and ensuring the quality of the product. The risk management tool used in this project is the fish bone map method. Failure Mode effect Analysis (FMEA) and Hazard Analysis critical Control Point (HACCP),) are used to evaluate the risk of workshop hardware, equipment, air conditioning purification system and so on. Through the 2010 version of GMP certification. According to the example of the small volume injection workshop certified by our company through version 2010 of GMP, it is determined that the visible foreign body produced during the production of small volume injection is still a continuing risk, and the factors leading to the risk are found by using the fish bone graph method. The risk of visible foreign bodies will be minimized by analyzing and studying, finding out the control measures and carrying out the implementation. Through the application of risk management in the transformation of 2010 GMP in the small volume injection production workshop, the small volume injection workshop of our company has been successfully certified by the national 2010 edition GMP. Then, risk management concept is continuously applied in the production process of GMP certification workshop to find out the risk points and control the visible foreign bodies in the production process. In the process of small volume injection production, risk management concepts and tools are continuously used to evaluate the risk of the production process, to formulate risk control measures, to continuously improve the production efficiency and to ensure the quality of the product.
【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R943
【参考文献】
相关期刊论文 前2条
1 朱富根;;浅谈大容量注射剂的风险管理[J];中国药物警戒;2010年08期
2 肖江宜;平其能;;质量风险管理在药品生产企业GMP实施中的应用[J];中国新药杂志;2009年22期
，本文编号：2381412
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