应用风险管理工具建立OOT类偏差调查流程—以氟康唑片溶.docx

最新 精品 Word 欢迎下载 可修改 摘 要 研究背景：偏差是药品生产过程中常见的一种现象，生产过程中的人、机、料、 法、环、测各个方面的异常均会引起偏差的出现。偏差的急时上报、系统调查、正 确处理及制定改进措施是保证产品质量的有力措施。但是由于生产环节的复杂多样， 许多偏差由于缺乏系统性调查，最终未能找到偏差产生的根源，致使偏差反复出现。 针对上述情况，本文试图以氟康唑片溶出度异常的偏差调查为例，建立一整套系统 偏差调查流程，为今后在大生产中出现的偏差，建立标准偏差调查模板。 研究方法：采用风险管理的方法，利用鱼刺图法，对可能引起偏差的人、机、 料、法、环各个因素时行评估和分析，最终确定关键控制参数，并对其时行分析。 研究结论：本次偏差主要发生在原辅料相溶性存在一定问题，实验结果显示不 同厂家的原辅料由于不同的生产工艺，所含杂质不同，经过生产过程中的湿热处理 后会发现一定的反应，可能会产生新的物质，导致药品质量发现变化。通过总结本 次偏差调查过程，我们针对生产过程偏差建立了偏差标准调查模板。在对偏差进行 分析时，应依据风险评估的原则，对人、机、料、法、环、测各个方面进行评估， 确定关键控制参数，再针对这此关键控制参数进行调查分析，避免盲目的用主观经 验去判断偏差的发生原因。 关键词：偏差调查；氟康唑；溶出度 Establish a Deviation Investigation Procedure for OOT Result— Apply the Risk Management Tool Abstract Background: It is very common to find deviations during pharmaceutical manufacturing process because of various abnormal aspects of the machine， material， method， ring， measuring and so on. It is necessary to report deviations timely， investigate the system and develop improvement measures correctly to ensure the quality of the product. However， due to the complexity and diversity of the production chain， many deviations recur again and again because of lacking of systematic investigation and failing to find the real causes of deviations. This paper attempts to take the abnormal dissolution deviation survey of fluconazole tablets for example to establish a set of system of deviation investigation process. We hope this model will be the standard deviation survey in future large-scale production deviation investigation. Research methods: This paper uses risk management methods and fishbone diagram methods to assess and analyze various aspects of the machine，material，method，ring， measuring and so on. We want to ultimately determine the critical control parameter and analyze its time line by these methods. Conclusions: The deviation occurs mainly in compatibility of different raw materials. The experimental results shows that different production processes will generate different impurities which would lead to r