CAJ | 학술논문

目的：掌握国际药品生产质量管理规范(GMP)认证检查情况，为我国药品检查政策的制定和药品检查体系建设提供依据。方法由17家省级药品检查机构对全国通过国际药品 GMP 认证的药品生产企业进行全面调研，方式包括问卷和实地调研。结果与结论国际认证更注重企业体系管理的完整性，国内认证过程则多注重具体条款的执行情况。建议借鉴国际认证检查方法，提高我国药品 GMP 检查员认证检查能力，探索认证检查改革程序，加强对药品质量相关支持系统的建设和管理，为企业提供国际认证相关培训和交流机会，从国家层面提高药品监管水平，对通过国际认证的企业给予政策支持，及时组织人员翻译国际药品GMP认证检查相关法律法规或者技术指南，改进我国的药品认证检查工作。
목적：장악국제약품생산질량관리규범(GMP)인증검사정황，위아국약품검사정책적제정화약품검사체계건설제공의거。방법유17가성급약품검사궤구대전국통과국제약품 GMP 인증적약품생산기업진행전면조연，방식포괄문권화실지조연。결과여결론국제인증경주중기업체계관리적완정성，국내인증과정칙다주중구체조관적집행정황。건의차감국제인증검사방법，제고아국약품 GMP 검사원인증검사능력，탐색인증검사개혁정서，가강대약품질량상관지지계통적건설화관리，위기업제공국제인증상관배훈화교류궤회，종국가층면제고약품감관수평，대통과국제인증적기업급여정책지지，급시조직인원번역국제약품GMP인증검사상관법율법규혹자기술지남，개진아국적약품인증검사공작。
Objective To understand the inspection status of international drug GMP certification and provide basis for establishment of drug inspection policy and construction of drug inspection system in China.Methods A comprehensive investigation was conducted by 1 7 provincial drug inspection institutions on pharmaceutical manufacturing enterprises certificated by international drug GMP in China. Questionnaire and on-the-spot investigation were performed. Results and Conclusion International certification paid more attention to the integrity of the enterprise system management while domestic certification attached more attention to the implementation of specific terms in the process of certification. In order to improve the pharmaceutical inspection work in China,it was recommended to take international certification inspection methods for reference to raise the inspector's competence of inspection,explore the a form on national certification inspection,improve the support system of drug quality,strengthen training and international exchange,improve the whole supervision level over drug throughout the country,give policy support to pharmaceutical companies which have passed the GMP inspection of WHO and so on,as well as provide prompt introduction of the international laws and regulations and guidelines related to GMP.