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GMP附录生效前计算机化系统合规策略探讨 被引量：7

Compliance strategy for legacy computerized system used before the implementation of GMP Annex
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摘要 《药品生产质量管理规范附件-计算机化系统》是药品生产企业所必需遵循的重要法规之一。对于法规生效之前已经投入使用的计算机化系统,本文参考了欧盟、PIC/S及FDA对此类计算机化系统的要求,结合本人经验提出了系统合规计划的策略。 《Chinese GMP Annex-computerized system》 is one of the fundamental regulations which should be followed by the pharmaceutical industry. The strategy for the compliance of legacy computerized system,which has been used before the regulation becomes effective,is proposed by referring to the foreign customs including EU GMP,PIC/S and FDA and moreover combining our previous project knowledge.
作者 郑茜 严伟民
机构地区 国药奇贝德(上海)工程技术有限公司 复旦大学药学院
出处 《上海医药》 CAS 2016年第5期69-71,共3页 Shanghai Medical & Pharmaceutical Journal
关键词 法规生效前计算机化系统 设备清单 差距分析 legacy computerized system inventory gap analysis
分类号 R951 [医药卫生—药学]
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参考文献7

  • 1国家食品药品监督管理总局.药品生产质量管理规范附件-计算机化系统[EB/OL].[2015-12-15].http://www.sda.gov.cn/WS01/CL0087/120500.html.
  • 2Pharmaceutical inspection convention & pharmaceutical inspection cooperation scheme. Good practice for computerised system in regulated "GxP" environment [EB/ OL]. [2015-12-15]. http://www.picscheme.org/publication. php.
  • 3International society for pharmaceutical engineering. GMAP5 a risk-based approach to compliant GxP eomputerised systems [EB/OL]. [2015-12-15 ]. http :// www2.ispe.org/imis/ISPE/Store/Category_Search_Results. aspx?InitialText=GAMP%205.
  • 4Food and drug administration department of health and human services. 21 CRF PARTS 11 electronic record; electronic signature [EB/OL] . [2015-12-15]. http://www.ecfr.gov/cgi- bin/text-idx?SID=3ee286332416f26a91 d9e6d786a604ab&mc =true&tpl=/ecfrbrowse/Title21/21 tab_02.tpl.
  • 5U.S. food and drug administration. Guidance for Industry Part l l,electronic record; electronic signature-scope and application [EB/OL] . [2015-12-15]. http://www.fda.gov/ regulatoryinformation/guidances/ucm 125067 .hUn.
  • 6European compliance academy. GMP advisor- the GMP question &answers guide version 01 april 2014[EB/OL] . [2015-12-15 ]. http ://www. gmp- compliance.org/eca_gmp- guide.html.
  • 7International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. Q9 quality risk management [EB/OL] . [2015-12-15]. http://www.ich.org/home.html.

共引文献1

同被引文献26

  • 1王飞,徐春丽.符合GMP要求的医药企业信息化系统[J].中国医药工业杂志,2006,37(4). 被引量：2
  • 2国家食品药品监督管理总局.药品生产质量管理规范附件-计算机化系统[EB/OL].[2015-12-15].http://www.sda.gov.cn/WS01/CL0087/120500.html.
  • 3国家食品药品临督管理总局.药品生产质量管理规范附录-计算机化系统[EB/OL].[2016-02-04].http://www.sda.gov.cn/WS01/CL0087/120500.html.
  • 4European compliance academy. FDA/EU-GMP-matrix completely revised[EB/OL]. [2016-02-04]. http://www. gmp-compliance.org/enews_04741_FDA-EU-GMP-Matrix- completely-revised.html.
  • 5European compliance academy. GMP advisor- the GMP question & answers guide version 01 april 2014 [EB/OL]. [2016-02-04]. http://www.gmp-compliance.org/eca_gmp- guide.html.
  • 6European compliance academy. ECA good practice guide GMP matrix[EB/OL]. [2016-02-04]. http://www.gmp- compliance.org/eca_handbuecher.html.
  • 7Pharmaceutical inspection convention & Pharmaceutical inspection cooperation scheme. Good practice for eom- puterised system in regulated "GxP" environment [EB/OL]. [2016-02-04]. http://www.picscheme.org/publication.php.
  • 8Medicines & healthcare products regulatory agency. GMP data Integrity definitions and guidance for industry [EB/OL]. [2016-02-04]. https://www.gov.uk/government/publications/ good-manufacturing-practice-data-integrity-definitions.
  • 9国家食品药品监督管理总局,药品生产质量管理规范[EB/OL].[2016-02-04].http://www.sda.gov.cn/WS01/CL0001.
  • 10European compliance academy. GMP advisor- the GMP question & answers guide version 01 april 2014[EB/OL]. [2015-12-15]. http://www.gmp-compliance.org/eca gmp- guide.html.

引证文献7

二级引证文献15

上海医药
2016年 第5期

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