【摘要】：在醫(yī)藥行業(yè),醫(yī)藥產(chǎn)品的制造過程管理必須全過程遵循《藥品生產(chǎn)質(zhì)量管理規(guī)范》(GMP)的要求,由于社會不斷發(fā)展變化,醫(yī)藥產(chǎn)品越來越豐富,出現(xiàn)了許多非常嚴重的藥害事件,各國藥品監(jiān)督管理機構(gòu)和醫(yī)藥界都越來越重視藥品生產(chǎn)質(zhì)量過程中的風(fēng)險管理,怎么樣才能將醫(yī)藥產(chǎn)品生產(chǎn)過程的風(fēng)險降到可接受水平是-個新的課題,有相當(dāng)重要的意義,這是對GMP十分必要的補充和完善,是確保醫(yī)藥產(chǎn)品安全,有效的必要舉措。醫(yī)藥產(chǎn)品從研發(fā),生產(chǎn),流通到臨床應(yīng)用,產(chǎn)品的組份,含量,有關(guān)物質(zhì),必然存在安全的風(fēng)險。醫(yī)藥產(chǎn)品存在多種風(fēng)險,質(zhì)量風(fēng)險是其中主要的一個。關(guān)鍵是必須認識到,醫(yī)藥產(chǎn)品質(zhì)量包含于整個的生命周期中,必須確保產(chǎn)品始終保持與臨床研究時的工藝質(zhì)量一致。 本文首先闡述了選題的研究背景及意義、國內(nèi)外關(guān)于質(zhì)量風(fēng)險管理研究現(xiàn)狀、本文的主要內(nèi)容及研究方法,為下文打下基礎(chǔ)；接著分析了質(zhì)量風(fēng)險管理相關(guān)理論原理,主要包括風(fēng)險管理、藥品的質(zhì)量風(fēng)險管理以及藥品質(zhì)量風(fēng)險管理的基本原則；進而對HY藥業(yè)公司質(zhì)量管理現(xiàn)狀進行了分析,提出了在企業(yè)推動質(zhì)量風(fēng)險管理工作的必要性；研究了企業(yè)各階段面臨的風(fēng)險,并在研究分析基礎(chǔ)上,結(jié)合HY公司特點,設(shè)計建立了一套符合該公司實際需求,具有較強操作性的質(zhì)量風(fēng)險管理體系�；诖梭w系,進一步列舉了運用已經(jīng)建立的風(fēng)險管理體系開展風(fēng)險管理活動的實例,證明了相應(yīng)的風(fēng)險管理體系的適用性,可行性。該體系的建立,為其他企業(yè)提供了有益的借鑒。
[Abstract]:In the pharmaceutical industry, the manufacturing process management of pharmaceutical products must follow the requirements of (GMP) in the whole process. Due to the continuous development and changes of society, pharmaceutical products are becoming more and more abundant, and many very serious drug hazards have occurred. Drug supervision and administration institutions and medical circles in various countries pay more and more attention to risk management in the process of drug production quality. How to reduce the risk of pharmaceutical product production process to acceptable level is a new subject, which is of great significance, which is a very necessary supplement and improvement to GMP, and is a necessary measure to ensure the safety and effectiveness of pharmaceutical products. Medical products from research and development, production, circulation to clinical application, product composition, content, related substances, there must be safety risks. There are many risks in pharmaceutical products, and quality risk is one of the main risks. The key is to recognize that the quality of pharmaceutical products is included throughout the life cycle and that the product must always be kept in line with the quality of the process at the time of clinical research. This paper first expounds the research background and significance of the selected topic, the research status of quality risk management at home and abroad, the main contents and research methods of this paper, which lays the foundation for the following, and then analyzes the relevant theoretical principles of quality risk management, including risk management, drug quality risk management and the basic principles of drug quality risk management. Furthermore, this paper analyzes the present situation of quality management in HY pharmaceutical company, puts forward the necessity of promoting quality risk management in enterprises, studies the risks faced by enterprises in each stage, and on the basis of research and analysis, combined with the characteristics of HY company, designs and establishes a set of quality risk management system which meets the actual needs of the company and has strong operation. Based on this system, this paper further enumerates the examples of using the established risk management system to carry out risk management activities, and proves the applicability and feasibility of the corresponding risk management system. The establishment of the system provides a useful reference for other enterprises.
【學(xué)位授予單位】：山東大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2013
【分類號】：F273.2;F426.72

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