中国药事
中國藥事
중국약사
CHINESE PHARMACEUTICAL AFFAIRS
2015年
2期
132-135
,共4页
药品生产质量管理规范%药品安全%风险防控%风险管理
藥品生產質量管理規範%藥品安全%風險防控%風險管理
약품생산질량관리규범%약품안전%풍험방공%풍험관리
GMP%drug safety%risk prevention and control%risk management
目的：探讨构建符合新版药品GMP要求的药品安全风险防控体系，为构建药品安全风险防范体系、降低药品安全风险、保证药品质量提供参考。方法：通过新版药品GMP中生产工艺和处方、原辅料准入、变更控制、偏差管理、药品不良反应、产品质量回顾六个关键点的介绍，分析了药品安全风险防控要点。结果与结论：从政府监管、行业自律和社会监督三个方面提出了构建符合新版药品GMP要求的药品安全风险防控体系的思路。
目的：探討構建符閤新版藥品GMP要求的藥品安全風險防控體繫，為構建藥品安全風險防範體繫、降低藥品安全風險、保證藥品質量提供參攷。方法：通過新版藥品GMP中生產工藝和處方、原輔料準入、變更控製、偏差管理、藥品不良反應、產品質量迴顧六箇關鍵點的介紹，分析瞭藥品安全風險防控要點。結果與結論：從政府鑑管、行業自律和社會鑑督三箇方麵提齣瞭構建符閤新版藥品GMP要求的藥品安全風險防控體繫的思路。
목적：탐토구건부합신판약품GMP요구적약품안전풍험방공체계，위구건약품안전풍험방범체계、강저약품안전풍험、보증약품질량제공삼고。방법：통과신판약품GMP중생산공예화처방、원보료준입、변경공제、편차관리、약품불량반응、산품질량회고륙개관건점적개소，분석료약품안전풍험방공요점。결과여결론：종정부감관、행업자률화사회감독삼개방면제출료구건부합신판약품GMP요구적약품안전풍험방공체계적사로。
Objective:To discuss establishment of a drug security risk prevention and control system for the new GMPtoreducedrug security risk and guarantee quality. Methods:Through introduction of production technique, prescription, access of primary excipients, change control, deviation management, adverse drug reaction and quality retrospection, the main points of drug security risk prevention and control were analyzed.Results and Conclusion:The ideas for establishment of the drug security risk prevention and control system for the new GMP were put forward from aspects of government supervision, industrial self-discipline and social supervision.
