网站大量收购独家精品文档,联系QQ:2885784924

欧盟GMP附录1分析.ppt

  1. 1、本文档共48页,可阅读全部内容。
  2. 2、原创力文档(book118)网站文档一经付费(服务费),不意味着购买了该文档的版权,仅供个人/单位学习、研究之用,不得用于商业用途,未经授权,严禁复制、发行、汇编、翻译或者网络传播等,侵权必究。
  3. 3、本站所有内容均由合作方或网友上传,本站不对文档的完整性、权威性及其观点立场正确性做任何保证或承诺!文档内容仅供研究参考,付费前请自行鉴别。如您付费,意味着您自己接受本站规则且自行承担风险,本站不退款、不进行额外附加服务;查看《如何避免下载的几个坑》。如果您已付费下载过本站文档,您可以点击 这里二次下载
  4. 4、如文档侵犯商业秘密、侵犯著作权、侵犯人身权等,请点击“版权申诉”(推荐),也可以打举报电话:400-050-0827(电话支持时间:9:00-18:30)。
查看更多
欧盟GMP附录1分析

Time for a new EU GMP “Sterile Products Annex” ? Or Sterile Products Processing Future Regulatory Compliance with what ??? Annex 1 Changes Proposal---- A significant review of Annex 1 of the EU GMP should be undertaken Because There have been many changes in practice and standards since Publication in 1997. Foundation in the 1983 UK Orange Guide GMP now showing its age. The Environmental requirements are the main areas requiring attention. Particle Classification Bio-contamination Control HEPA filter selection Filter Testing Room Pressurisation Air exchange rates Uni-directional airflow system velocity Performance Monitoring Harmonisation OR Proliferation Order to the confusion EU GMP Annex 1 content 1-6 General environmental requirements 7-9 Isolation technology 10 Blow-fill-seal technology 11 Terminally sterilised products 12 Aseptic preparation 13-21 Personnel 22-31 Premises 32-36 Equipment EU GMP Annex 1 content 37-39 Sanitation 40-54 Processing [note: clause 42 revised July 2001 to modify “Process simulation media fill” objectives and requirements] 55-61 Sterilisation 66-68 Moist heat 69 Dry heat 70-75 Irradiation EU GMP Annex 1 content 76-81 Ethylene oxide 82-87 Filtration of medicinal products 88-90 Finishing of sterile products 91-93 Quality control New Standards “Cleanroom” “Air Filtration” The Standards are Generic - not application specific The status of the Standards being prepared by ISO TC 209 Classification by airborne 14644-1 Published Monitoring for Compliance 14644-2 Published Measurement Testing 14644-3 CD-DIS Design, Construction, Start-up 14644-4 Published Cleanroom Operations 14644-5 DIS-FDIS Separative Devices 14644-7 DIS-FDIS Bio-contamination Control 14698-1,2 3 2nd DIS Terms and definitions 14644-6 CD Molecular Contamination 14644-8 WD Status of US Fed Std 209E November 2001 Status of US Fed Std 209E November 2001 EN ISO 14644-12 have been published, IEST have recommended to the US GSA that maintenance of US Fed Std 209 be suspe

文档评论(0)

ligennv1314 + 关注
实名认证
内容提供者

该用户很懒,什么也没介绍

1亿VIP精品文档

相关文档