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 radiopharmaceuticals 辐射药品生产 Annex 4Manufacture of veterinary medicinal products other than immunologicals 非疫苗类兽药生产...
PE 009- 16标准开始生效 1 February 2022 2022年2月1日 Revision History 修订历史 Date Version Number Reasons for revision 21 December 2000 2000年12月21日 PH 1/97 (Rev.) Revision of Annex 14 修订附录14 Renumbering of all annexes 所有附录重新编号 ...
x 结合了修订版的无菌附录1，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...
PICS PE009-10(Annexes) 2013药品GMP指南附件11 计算机系统(中英文).docx,PIC/S PE009-10(Annexes) 20130101 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 GU
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 ...
Revision of Chapter 1 1 June 2006 PE 009-4 ? Revision of Chapter 6 1 August 2006 PE 009-5 Corrections to revision of Chapter 6 Revision of Chapter 8 5 April 2007 PE 009-6 Reorganisation of the PIC/S GMP Guide in Part I, Part II and Annexes Incorporation of PE 007 (APIs guide) ...
要是ISO、PDA这种本身不免费的你拿来收费就算了，这种公共的GMP规范还好意思让大家花钱购买，你以为只有...
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...
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 radiopharmaceuticals 辐射药品生产 Annex 4Manufacture of veterinary medicinal products other than immunologicals 非疫苗类兽药生产...
PE 009- 16标准开始生效 1 February 2022 2022年2月1日 Revision History 修订历史 Date Version Number Reasons for revision 21 December 2000 2000年12月21日 PH 1/97 (Rev.) Revision of Annex 14 修订附录14 Renumbering of all annexes 所有附录重新编号 ...