CAJ | 학술논문

目的研究建立符合新版药品生产质量管理规范(2010年修订)要求的水痘减毒活疫苗生产厂房的用户需求标准(user requirement specification,URS).方法将生产厂房的URS分为工艺、设施、设备、环境健康安全四大部分,并分别按简介、法规标准、正文、修订历史等内容格式进行描述.结果简介部分包括项目介绍、文件的范围和目的、术语等.法规标准包括行业法规、设计标准、建设标准、企业标准等.正文部分则详细描述工艺、设施、设备、环境健康安全等方面的要求.修订历史部分由修订版本、修订时间和原因简述等内容构成.结论建立了符合新版药品生产质量管理规范的水痘减毒活疫苗生产厂房的用户需求,为实施新版规范奠定了基础.
목적 연구건립부합신판약품생산질량관리규범(2010년수정)요구적수두감독활역묘생산엄방적용호수구표준(user requirement specification,URS).방법 장생산엄방적URS분위공예、설시、설비、배경건강안전사대부분,병분별안간개、법규표준、정문、수정역사등내용격식진행묘술.결과 간개부분포괄항목개소、문건적범위화목적、술어등.법규표준포괄행업법규、설계표준、건설표준、기업표준등.정문부분칙상세묘술공예、설시、설비、배경건강안전등방면적요구.수정역사부분유수정판본、수정시간화원인간술등내용구성.결론 건립료부합신판약품생산질량관리규범적수두감독활역묘생산엄방적용호수구,위실시신판규범전정료기출.
Objective To explore and establish user requirement specification (URS) for live attenuated varicella vaccine facility conforming to the requirement of Good Manufacturing Practice for Drugs (2010 Revision).Methods The URS was composed of 4 part:process,facilities,equipments,and environment health safety (EHS),each included general introduction,normative references,text,and revision history.Results The general introduction included project overview,scope and purpose of the document,terminology,etc.The normative references consisted of industry regulations,design standards,construction standards,corporate standards,etc.The text specified the requirement for process,facilities,equipments,EHS.The revision history described the data of revised version,revision date and brief description.Conclusion The URS for live attenuated varicella vaccine facility in compliance with the revised good manufacturing practice (GMP) standard is well developed,which lays the foundation of implementation of the new revision GMP.