CAJ | 학술논문

目的：掌握实施新版《药品生产质量管理规范》(GMP)后制药企业质量保证系统运行情况与存在问题，为我国新版药品GMP认证检查工作提供参考。方法采用问卷调研与现场检查及药品 GMP 认证相结合的方式，对164家制药企业的质量保证系统运行情况进行调研。结果与结论制药企业的质量保证系统仍存在质量保证人员配备不足、人员培训不到位；偏差处理体系操作规程不合理，偏差漏报；产品质量回顾分析工作整体水平较差；质量风险管理在药品生产质量保证系统中工作基础较差等问题。建议通过加强新修订药品GMP法律地位的宣贯；为企业提供更多的新修订药品 GMP 培训与引导；出台质量受权人的职业权力保障政策等措施，促进制药企业质量保证系统的完善。
목적：장악실시신판《약품생산질량관리규범》(GMP)후제약기업질량보증계통운행정황여존재문제，위아국신판약품GMP인증검사공작제공삼고。방법채용문권조연여현장검사급약품 GMP 인증상결합적방식，대164가제약기업적질량보증계통운행정황진행조연。결과여결론제약기업적질량보증계통잉존재질량보증인원배비불족、인원배훈불도위；편차처리체계조작규정불합리，편차루보；산품질량회고분석공작정체수평교차；질량풍험관리재약품생산질량보증계통중공작기출교차등문제。건의통과가강신수정약품GMP법률지위적선관；위기업제공경다적신수정약품 GMP 배훈여인도；출태질량수권인적직업권력보장정책등조시，촉진제약기업질량보증계통적완선。
Objective To investigate the operation situation and existing problems of quality assurance system of drug manufacturing enterprises after implementation of the new GMP, so as to provid a reference for new drug GMP certification and inspection in China.Methods The operation situation of quality assurance system of 164 pharmaceutical enterprises was analyzed by adopting the integration of questionnaire survey and on-site inspection or drug GMP certification.Results and Conclusion Problems, such as inadequate quality assurance personnel and lack of personnel training,still existed in quality assurance system of pharmaceutical enterprises;problems still existed in the error treatment system, including unreasonable operating procedures and failure to report errors;overall level of retrospective analysis on product quality review was poor;work foundation of quality risk management in quality assurance system was weak.It was recommended to provide more training and guidance to the newly revised GMP for enterprises by strengthening the implementation of legal status of the new revised GMP;professional right safeguard policies for quality authorized person should be unveiled to promote the completion of quality assurance system for the pharmaceutical enterprises.