| PIC/S、PIC/S GMP与中国GMP的比较研究 |
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| 引用本文： | 张卓光.PIC/S、PIC/S GMP与中国GMP的比较研究[J].中国药事,2010,24(3):302-305. |
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| 作者姓名： | 张卓光 |
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| 作者单位： | 成都生物制品研究所,成都,610023 |
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| 摘 要： | 目的介绍药品监管公约/药品监管合作计划（PIC/S）和PIC/S GMP,比较PIC/S GMP和中国GMP（98修订）的差异。方法从历史变革、机构与运行机制、宗旨以及PIC/S GMP的影响来阐述PIC/S;从人员、硬件、软件等方面来比较PIC/S GMP与中国GMP。结果PIC/S在药品领域倡导GMP标准、检查一致以及互认,促进了GMP发展。结论PIC/S GMP是国际上高水平的GMP。
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| 关 键 词： | 药品监管公约 药品监管合作计划 药品生产质量管理规范 |
Compare Research of PIC/S,PIC/S GMP and Chinese GMP |
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| Zhang Zhuoguang.Compare Research of PIC/S,PIC/S GMP and Chinese GMP[J].Chinese Pharmaceutical Affairs,2010,24(3):302-305. |
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| Authors: | Zhang Zhuoguang |
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| Institution: | Zhang Zhuoguang(Chengdu Institute of Biological Products,Chengdu 610023) |
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| Abstract: | Objective To introduce PIC/S and PIC/S GMP,Comparing PIC/S GMP with Chinese GMP(98 Edition).Methods Presenting PIC/S from history,organization,operating and mission,and the influence of PIC/S GMP.Comparing PIC/S GMP with Chinese GMP from person,hardware and software.Results PIC/S is to lead the international development,implementation and maintenance of harmonized GMP standard and quality systems of inspectorates in the field of medicinal products.Conclusion PIC/S GMP standards are high. |
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| Keywords: | Pharmaceutical Inspection Convention(PIC) Pharmaceutical Inspection Co-operation Scheme(PIC/S) Good Manufacturing Practice(GMP) |
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