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差距分析法检查GMP附录生效前计算机化系统的合规性 被引量：5

Examination of computerized system compliance by gap analysis before GMP Annex coming into force
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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。对于法规生效前的计算机化系统,合规的关键是根据差距分析法提出整改措施。差距分析可根据4大类检查标准,将系统的现状与其进行对比,从而判断系统是否符合要求。如检查的结果不符合要求,需进行整改。 ＂Chinese GMP Annex-computerized system＂ is one of the fundamental regulations which should be followed by the pharmaceutical industry. For the legacy system which has been used before the regulation becoming effective, it is necessary to fix the correction suggestion through the gap analysis. Whether or not the system meets the requirements could be determined by comparing four categories of audit standards with system＇s current situation. Moreover, the correction must be carried out if the results of the examination would not meet the requirements.
作者 郑茜 李莺 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11期78-80,共3页 Shanghai Medical & Pharmaceutical Journal
关键词 法规生效前计算机化系统 差距分析 检查标准 整改建议 legacy computerized gap analysis audit standards correction suggestion
分类号 R95 [医药卫生—药学]
  • 相关文献

参考文献8

  • 1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.
  • 2European 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.
  • 3European 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.
  • 4European compliance academy. ECA good practice guide GMP matrix[EB/OL]. [2016-02-04]. http://www.gmp- compliance.org/eca_handbuecher.html.
  • 5Pharmaceutical 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.
  • 6Medicines & 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.
  • 7郑茜,严伟民.GMP附录生效前计算机化系统合规策略探讨[J].上海医药,2016,37(5):69-71. 被引量：7
  • 8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.

二级参考文献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6

同被引文献15

引证文献5

二级引证文献10

上海医药
2016年 第11期

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