中国药事
中國藥事
중국약사
Chinese Pharmaceutical Affairs
2015年
9期
895-899
,共5页
产品立项%药学研究%质量管理体系%药品注册
產品立項%藥學研究%質量管理體繫%藥品註冊
산품립항%약학연구%질량관리체계%약품주책
project%pharmaceutical research%quality management system%drug registration
目的:为项目的选择和药学研究结果的真实性、有效性、完整性提供帮助。方法:从立项和药学研究两个方面,阐述项目调研和药学研究质量管理体系构建的几个关键点,为研发机构选择产品和建立完善的药学研究质量管理体系提供建议。结果:为保证立项合理以及研发工作的有序开展和规范管理,企业应当进行充分调研,并参考GMP的思路构建与研发相匹配的软件和硬件管理体系。结论:立项和药学研究是药物研发过程中很重要的两个阶段,应对其实行书面化管理,以便直观地反映出机构的研发能力和产品质量。
目的:為項目的選擇和藥學研究結果的真實性、有效性、完整性提供幫助。方法:從立項和藥學研究兩箇方麵,闡述項目調研和藥學研究質量管理體繫構建的幾箇關鍵點,為研髮機構選擇產品和建立完善的藥學研究質量管理體繫提供建議。結果:為保證立項閤理以及研髮工作的有序開展和規範管理,企業應噹進行充分調研,併參攷GMP的思路構建與研髮相匹配的軟件和硬件管理體繫。結論:立項和藥學研究是藥物研髮過程中很重要的兩箇階段,應對其實行書麵化管理,以便直觀地反映齣機構的研髮能力和產品質量。
목적:위항목적선택화약학연구결과적진실성、유효성、완정성제공방조。방법:종립항화약학연구량개방면,천술항목조연화약학연구질량관리체계구건적궤개관건점,위연발궤구선택산품화건립완선적약학연구질량관리체계제공건의。결과:위보증립항합리이급연발공작적유서개전화규범관리,기업응당진행충분조연,병삼고GMP적사로구건여연발상필배적연건화경건관리체계。결론:립항화약학연구시약물연발과정중흔중요적량개계단,응대기실행서면화관리,이편직관지반영출궤구적연발능력화산품질량。
Objective: To provide help for project selection and authenticity, validity and integrity of results of pharmaceutical research.Methods:The article described the key points for research project and construction of quality management system of drug research and development. Suggestions for relevant companies to select products were provided, and the quality management system of drug research and development was established and perfected.Results: To ensure reasonable selection, orderly research and standardized management, R&D institution should make full investigation, establish software and hardware management system consistent with GMP and the R & D level. Conclusion:Project and drug R&D, which are two important stages of drug development, are needed to be documented, so as to directly relfect research and development ability of R&D institution and the quality of the project.