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论文编号：	14168
作者编号：	2320190593
上传时间：	2023/12/7 16:06:45
中文题目：	KD无菌注射剂工厂生产偏差管理改进研究
英文题目：	Research on the Improvement of Deviation Management of Production in KD Factory of Sterile Injection
指导老师：	车建国
中文关键字：	偏差；失效模式和影响分析；统计过程控制；无菌注射剂
英文关键字：	Deviation; Failure Mode and Impact Analysis; Statistical Process Control; Sterile Injection
中文摘要：	无菌注射剂作为医药产品的一种特殊剂型，具有复杂的生产工艺和高风险的给药途径，在生产制造过程中要严格遵循《药品生产质量管理规范》（GMP）的要求。偏差管理是质量管理体系中重要组成部分，制药企业需要建立一个科学有效的偏差管理流程，持续改进和完善药品质量的有效控制。 本文针对KD无菌注射剂工厂面临的偏差发生过多的问题，运用失效模式和影响分析（FMEA）的理念和统计过程控制（SPC）工具，对企业的偏差管理流程进行优化搭建，提升偏差预防和处理的科学性和有效性，以及生产过程的稳定性以减少偏差。 本文首先阐述了本文研究的背景、目的和意义，描述了制药行业偏差管理和质量风险管理的研究现状、原则和基本流程，并介绍了FMEA和SPC基本理论知识。其次，通过介绍KD无菌注射剂工厂在生产过程中偏差发生过多等问题，进行了根本原因和影响因素分析。然后根据以上原因，结合无菌注射剂生产工艺的特点，运用FMEA理论，对偏差管理流程进行改进和实施。改进后的流程分为偏差预防流程、偏差处理流程和偏差回顾流程。第一，在偏差预防流程中结合了FMEA中的风险识别、控制、分析、评价等方法，提升偏差发生的事前预防能力，并运用SPC控制图工具评价过程控制状态和能力。以生产制备工序为例，介绍了其在工厂的实施过程。第二，将鱼骨图、5W根本原因分析工具和改进效果评价加入到偏差的处理流程中，提升偏差处理的有效性，并以一个实际发生的偏差案例，介绍了在新偏差处理流程中偏差的处理。第三，在偏差回顾流程中，将偏差的定期回顾和风险基线回顾结合，使偏差管理流程形成回环，不断降低生产过程存在的风险，完善和提升过程的稳定性。最后，评价了偏差管理流程改进和实施的成果，并总结其不足，为其下一步优化提出设想和展望。
英文摘要：	As a special formulation of pharmaceutical product, sterile injection has complex manufacturing process and high-risk route of administration, so it should strictly follow the requirements of 《Good Manufacturing Practice》(GMP). Deviation management is an important part of the quality management system. The Pharmaceutical company need to establish a scientific and effective quality deviation management system in order to improve the quality control of products continuously. To reduce the high rate of deviation occurred in KD factory of sterile injection, this thesis uses the concept of failure mode and impact analysis (FMEA) and statistical process control (SPC) tools to optimize and rebuild the deviation management system, so as to improve the prevention and treatment of deviation scientifically and effectively, as well as the stability of the manufacturing process, so as to reduce the occurred deviation. Firstly, the thesis states the background, purpose and significance of this research, and also represents the current status of research, principle and basic process of deviation management and quality risk management in the pharmaceutical industry. As well, it introduces the basic theoretical knowledge of FMEA and SPC. Secondly, the thesis analyzes the reason for the imperfection of deviation management in KD sterile injection factory by introducing the high rate of deviation occurred in manufacturing process. Upon above the reasons, the thesis uses theory of FMEA combined with characteristics of manufacturing process for sterile injection to rebuild and implement the deviation management system. The newly established system is divided into three parts: deviation prevention process, handling process and review process. In the deviation prevention process, it combines the FMEA method of risk identification, control, analysis and evaluation to improve the preventive ability of deviation occurred. Also the SPC control chart is used to evaluate the status and ability of process control. Taking the formulation preparation process as an example, its implementation process in the factory is introduced. In the deviation handling process, the tools of fishbone diagram, 5W root cause analysis and effective evaluation of improvement are used to improve the effectiveness of deviation handling. Taking an actual deviation case occurred as an example, the new deviation handling process is introduced. In the deviation review process, the regular review of deviation is combined with the review of risk baseline to form a loop in deviation management system, in order to reduce the risks in the manufacturing process and improve the stability of the process continuously. Finally, the thesis evaluates the results of build and implementation of deviation system, and summarizes the experiences and shortcomings. The ideas and prospects for further optimization are also put forward.
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