CAJ | 학술논문

新版《药品生产质量管理规范》要求制药企业必须建立完善的质量管理体系，在质量管理中变更管理是保证药品质量的重要组成部分，强调在实施 GMP 时要求企业建立完善的变更控制流程，以保证产品质量。从发起、分析、规划和审批、执行、实施等方面介绍了变更流程。指出制药企业的任何变更都应遵守国家药监局新版 GMP变更控制的要求，确保制药标准的权威性，防止随意变换，便于质量追溯及产品质量跟踪，为质量信息系统提供基础信息。
신판《약품생산질량관리규범》요구제약기업필수건립완선적질량관리체계，재질량관리중변경관리시보증약품질량적중요조성부분，강조재실시 GMP 시요구기업건립완선적변경공제류정，이보증산품질량。종발기、분석、규화화심비、집행、실시등방면개소료변경류정。지출제약기업적임하변경도응준수국가약감국신판 GMP변경공제적요구，학보제약표준적권위성，방지수의변환，편우질량추소급산품질량근종，위질량신식계통제공기출신식。
According to the new edition GMP,pharmaceutical enterprises should establish a complete quality management system,in which a change control system is one of the major components. During the GMP implementation process, enterprises are also required to set up a complete control flow for changes to ensure product quality. This paper describes the changing process from the aspects of initiation,plan & approval,execution & following up. It points out that any quality-related change in the companies shall conform to the requirements on change control in the new edition GMP issued by the State Food and Drug Administration(SFDA)to maintain the authority of the standard and guard against any freely changing. This will help in the quality tracing and following-up of relative products and provide basic information to the quality infor-mation system.