期刊文献+

最终灭菌药品参数放行在我国医药企业实施的可能性研究 被引量:1

The study on the feasibility of implementing terminally sterilized drugs parametric release in our pharmaceutical industry
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摘要 针对我国当前频繁发生的医药事故,结合我国医药企业GMP的实施情况,对最终灭菌药品的参数放行进行了理论分析,以探讨我国医药企业实施参数放行的可能性。 For frequent occurrence of pharmaceutical accident in our country, we combine the implementation of GMP in pharmaceutical industry, and analyze parametric release of terminally sterilizes drugs in theory, to explore the feasibility of implementing parametric release in our pharmaceutical industry.
出处 《机电信息》 2016年第2期1-6,44,共7页
关键词 参数放行 无菌检测 GMP Parametric Release Sterility Test GMP
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  • 1中国医药经济网[EB/OL].[2009-03-08].http://www.menet.com.cn.
  • 2国家食品药品监督管理局网站.2008年度统计年报[EB/OL].[2009-03-208].http://www.sda.gov.cn.
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  • 4Associate commissioner for regulatory affairs. United States Food and Drug Administration compliance policy guide 7132a. 13. Parametric release-terminally heat sterilized drug products[S].
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  • 6Parenteral drug association, Inc. Technical monograph No. 1. Validation of steam sterilization cycles[S].
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  • 9ISO 11134. Sterilization of health care products-Requirements for validation and routine control-Industrial moist heat sterilization[S].
  • 10The European agency for the evaluation of medicinal product CPMP/QWP3015/99. Note for guidance on parametric release[S].

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