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全国药品认证机构现状及分析 被引量:2

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摘要 从经费来源、认证范围、人员、信息化建设等方面介绍全国药品认证机构的现状,并对其存在的问题进行分析,提出见解。
作者 樊晓东
出处 《首都医药》 2009年第12期13-14,共2页 Capital Medicine
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同被引文献18

  • 1国家食品药品监督管理局药品认证管理中心.关于印发《药品检查机构能力评估手册(试行)》的通知[z].药认[2011]45号,2011.
  • 2International Organization tor Standardization. About/SO [EB/OL].http://www.iso.org/iso/about.htm.2011-10-06. 2011-12-27.
  • 3International Organization for Standardization. Quality ma- nagement and quality assurance[EB/OL ].http ://www.iso. org/iso/iso_catalogue/catalogue_ics/catalogue_ics_browse. htm?ICS 1 =3&ICS2=120&ICS3=I O&published=on.2005- 10-03.2011-08-11.
  • 4WHO Expert Committee on Specifications for Pharmaceu- ileal Preparations. Quality systems requirements for na- tional good manufacturing practice inspectorates: WHO Technical Report Series No.902[R]. Geneva: World Heal- th Organization, 2002: 101-118.
  • 5PIC/S Secretariat. Recommendations on Quality System Requirements for Pharmaceutical lnspectorates[M].Gene- va: Pharmaceutical Inspection Convention and Pharmaceu- tical Inspection Co-operation Scheme, 2007:1-9.
  • 6中国合格评定国家认可委员会.检查机构能力认可准则[S].CNAS-C101,2006:1-10.
  • 7International Organization for Standardization. Gener- al criteria for the operation of various types of bodies per- forming inspection[S]. ISO/IEC 17020,1998:1-7.
  • 8International Organization for Standardization. Quality ma- nagement systems-fundamentals and vocabulary[S]. ISO 9000,2005: 1-19.
  • 9International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Hu- man Use. ICH harmonized tripartite guideline: Quality Risk Management Q9[EB/OL]. http://www.ich.org/filead- min/Public_Web_Site/ICH_Products/Guidelines/Quality/ Qg/Step4/Qg_Guideline.pdf.2005-11-09.2011-08-11.
  • 10Pharmaceutical Inspection Convention and Pharmaceuti- cal Inspection Co-operation Scheme. Participating Author- ities[EB/OL], http ://www.picscheme.org/members.php. 2011-05-09.2011-08-11.

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