info@picscheme.org web site: https://www.picscheme.org 网站: https:// www.picscheme.org PE 009-17 (Annexes) 25 August 2023 PE 009-17(附件) 2023 年 8 月 25 日 北京齐力佳科技有限公司提供 2023-06-24本文件来自网络,翻译来自翻译网站,本文仅供个人学习使用,齐力佳不保证原文及翻译的准确性完...
ADOPTION AND ENTRY INTO FORCE Adoption by the Committee of PE 009- 16 26 January 2022 Entry into force of PE 009- 16 1 February 2022 REVISION HISTORY Date Version Number Reasons for revision 21 December 2000 PH 1/97 (Rev.) Revision of Annex 14 Renumbering of all annexes Change in the ...
annexes.AspecificglossaryforAPIscanbefoundattheendofPartII. 本指南分为两部分,包含多个附录,附录对两部分皆适用。第一部分涵盖药品生产GMP原则;第二部分涵盖用作起始物料 的活性物质(原料药)生产GMP原则;附录针对不同领域的活动提供详细信息。对于某些生产工艺,不同的附录可同时适 ...
希望看到中英文版本的
PIC/SGMP从2021年的15版，到2022年EU GMP附录1更新后的16版，再到这一次刚刚发布的17版，很频繁，...
PE 009-10 (Annexes) 1 January 2013 GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS 药品GMP指南 ANNEXES 附件 ANNEXES附件目录 Annex 1Manufacture of sterile medicinal products 无菌药品生产 Annex 2Manufacture of biological medicinal products for human use 人用生物制品生产 Annex 3Manufacture of...
PIC/S PE009-10(Annexes)药品GMP指南附件11 计算机系统 PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPEC TION CO-OPERATION SCHEME PE 009-10 (Annexes) 1 January 2013 GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS 药品GMP指南 ANNEXES 附件 ANNEX 11 附件11 COMPUTERISED SYSTEMS 计算机系统...
内容提示: PIC/S PE009-10(Annexes) 20130101 药品GMP 指南附件 15 确认和验证(中英文) PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPEC TION CO-OPERATION SCHEME PE 009-10 (Annexes) 1 January 2013 GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS 药品 GMP 指南 ANNEXES 附件 ANNEX 15 ...
PE 009-10 (Annexes) 1 January 2013 GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS 药品GMP指南 ANNEXES 附件 ANNEXES附件目录 Annex 1Manufacture of sterile medicinal products 无菌药品生产 Annex 2Manufacture of biological medicinal products for human use 人用生物制品生产 Annex 3Manufacture of...
PE 009-14(Annexes) -iv- 1 July2018Table of contents ChangeControl 139Glossary 140 Annex 16[Qual ified person and batch release]∗ 144 Annex 17(Real Time Release Testing and Parametric Release) 145Principle 145Scope 145Real Time Release Testing(RTRT) 145ParametricReleaseandSteri l isation 147...