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随着药品生物制品企业质量管理工作的发展，特别是对ＧＭＰ的实施，质量保证（ＱＡ）逐渐成为生物制品企业的重要的质量管理体系。尽管ＱＣ和ＧＭＰ都是ＱＡ 的重要组成，但由于ＱＡ 作为特定的管理体系，在国内生物制品企业还始建不久，尚未形成适合本国企业的ＱＡ 理论体系，所以有必要结合国内外的经验开展ＱＡ 的理论研究，以有助于ＱＡ 工作的更有效的开展。本文对构成ＱＡ 体系中组织、计划、过程、因素、ＱＡ 方法等要素的内涵、相互关系以及与ＧＭＰ、ＱＣ、企业行政管理等外部要素的关系进行综述，旨在探讨ＱＡ 活动的规律性，以指导ＱＡ 的实践。
With the development of quality management of pharmaceutical and biological products companies, especially the implementation of GMP, quality assurance (QA) has gradually become an important quality management system for biological products companies. Although both QC and GMP are important components of QA, QA as a specific management system has not yet formed a QA theoretical system suitable for domestic companies soon after the establishment of a domestic biological product company. Therefore, it is necessary to combine QA with domestic and international experience. Theoretical research to help the more effective development of QA work. This article reviews the connotations, interrelationships, and external relations of GMP, QC, and corporate governance, and other elements that make up the QA system’s organization, plans, processes, factors, and QA methods, and aims to explore the regularity of QA activities. Guide QA practice.