药用辅料生产企业第三方审计实施要点分析
发布时间：2019-03-26 17:36
【摘要】：为建立科学的药用辅料管理制度,2010年9月16日国家食品药品监督管理局发布了《药用原辅材料备案管理规定》(征求意见稿),明确提出了药品生产企业对其使用的药用辅料生产企业负有质量审计责任。2012年8月1日,SFDA又发布了《加强药用辅料监督管理的有关规定》,以进一步加强药用辅料生产和使用管理,保证药品质量。 随着市场经济的发展,第三方审计的应用越来越宽广,药品生产企业对第三方质量审计的期望也越来越高,因此,第三方审计的责任也越来越大。药用辅料生产企业在进行第三方审计的同时,相应产生了一定的审计风险。 本文论文分为四个部分：第一部分明确审计的含义、分类及审计对象；第二部分具体了第三方审计的含义,并通过第一方、第二方审计的缺陷、国内外第三方审计的成熟性、国内相关政策驱动及药品生产企业和辅料生产企业的多个角度分析第三方审计的必然性,阐述包括配置、流程、内容、标准在内的第三方审计的相关内容；第三部分主要从审计主体、客体等不同立场分析第三方审计风险;最后一部分则是主要根据《合同法》相关法规法条,探讨第三方审计中的民事合同关系。 本研究旨在分析第三方审计过程中的实施要点,提出科学合理的审计行为方式,帮助药品生产企业及药用辅料生产企业进行高效、科学的质量审计,有效的促进国内辅料行业和第三方审计机构的发展。
[Abstract]:In order to establish a scientific management system for medicinal auxiliary materials, on 16 September 2010, the State Food and Drug Administration issued the regulations on the filing and Management of Medicinal raw and auxiliary materials (draft for comments). It is clearly pointed out that pharmaceutical manufacturers have the responsibility of quality audit for pharmaceutical auxiliary materials production enterprises. On Aug. 1, 2012, SFDA issued the relevant regulations on strengthening Supervision and Management of Medicinal Auxiliary Materials. In order to further strengthen the production and use of pharmaceutical accessories management, to ensure the quality of drugs. With the development of market economy, the application of the third-party audit is wider and wider, and the expectation of the third-party quality audit is higher and higher. Therefore, the responsibility of the third-party audit is more and more large. At the same time, the third-party audit of the pharmaceutical auxiliary material production enterprises produces certain audit risks. This paper is divided into four parts: the first part clarifies the meaning, classification and object of audit; The second part specifies the meaning of the third-party audit, and through the defects of the first party and the second-party audit, the maturity of the third-party audit at home and abroad. It analyzes the inevitability of the third-party audit from the aspects of domestic policy-driven and pharmaceutical and auxiliary material production enterprises, and expounds the relevant contents of the third-party audit including configuration, process, content and standard. The third part mainly analyzes the third-party audit risk from the different positions of audit subject and object, and the last part mainly discusses the civil contract relationship in the third-party audit according to the relevant laws and regulations of the contract Law. The purpose of this study is to analyze the key points in the process of third-party audit, put forward a scientific and reasonable way of auditing behavior, and help pharmaceutical manufacturers and pharmaceutical auxiliary materials manufacturers to conduct efficient and scientific quality audits. Effectively promote the development of domestic accessories industry and third-party audit institutions.
【学位授予单位】：成都中医药大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：F239.4
本文编号：2447771
[Abstract]:In order to establish a scientific management system for medicinal auxiliary materials, on 16 September 2010, the State Food and Drug Administration issued the regulations on the filing and Management of Medicinal raw and auxiliary materials (draft for comments). It is clearly pointed out that pharmaceutical manufacturers have the responsibility of quality audit for pharmaceutical auxiliary materials production enterprises. On Aug. 1, 2012, SFDA issued the relevant regulations on strengthening Supervision and Management of Medicinal Auxiliary Materials. In order to further strengthen the production and use of pharmaceutical accessories management, to ensure the quality of drugs. With the development of market economy, the application of the third-party audit is wider and wider, and the expectation of the third-party quality audit is higher and higher. Therefore, the responsibility of the third-party audit is more and more large. At the same time, the third-party audit of the pharmaceutical auxiliary material production enterprises produces certain audit risks. This paper is divided into four parts: the first part clarifies the meaning, classification and object of audit; The second part specifies the meaning of the third-party audit, and through the defects of the first party and the second-party audit, the maturity of the third-party audit at home and abroad. It analyzes the inevitability of the third-party audit from the aspects of domestic policy-driven and pharmaceutical and auxiliary material production enterprises, and expounds the relevant contents of the third-party audit including configuration, process, content and standard. The third part mainly analyzes the third-party audit risk from the different positions of audit subject and object, and the last part mainly discusses the civil contract relationship in the third-party audit according to the relevant laws and regulations of the contract Law. The purpose of this study is to analyze the key points in the process of third-party audit, put forward a scientific and reasonable way of auditing behavior, and help pharmaceutical manufacturers and pharmaceutical auxiliary materials manufacturers to conduct efficient and scientific quality audits. Effectively promote the development of domestic accessories industry and third-party audit institutions.
【学位授予单位】：成都中医药大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：F239.4
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