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没想到法规指南的学习是一条漫长艰辛的路，学的还没各国更新来的快，继续冲，不放弃！
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PE 009-17 GMP Guide 绪论（介绍）中英文对照.pdf
202.89 KB, 下载次数: 214
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pe-009-17-gmp-guide-intro.pdf
178.36 KB, 下载次数: 137
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pe-009-17-gmp-guide-part-i-basic-requirements-for-medicinal.pdf
525.1 KB, 下载次数: 163
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pe-009-17-gmp-guide-part-ii-basic-requirements-for-apis.pdf
566.36 KB, 下载次数: 140
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pe-009-17-gmp-guide-xannexes.pdf
2.26 MB, 下载次数: 152
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PE 005-4 PIC S GOOD PRACTICE GUIDELINES FOR BLOOD ESTABLISHMENTS AND HOSPITAL BL.pdf
510.87 KB, 下载次数: 149
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PE 010-4 PIC S GUIDE TO GOOD PRACTICES FOR THE PREPARATION OF MEDICINAL PRODUCTS.pdf
217.36 KB, 下载次数: 136
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PE 011-1 PIC S GUIDE TO GOOD DISTRIBUTION PRACTICE FOR MEDICINAL PRODUCTS.pdf
195.63 KB, 下载次数: 145
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PI 005-3 GUIDANCE ON PARAMETRIC RELEASE.pdf
164.92 KB, 下载次数: 119
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PI 006-3 VALIDATION MASTER PLAN INSTALLATION AND OPERATIONAL QUALIFICATION NON-S.pdf
226.77 KB, 下载次数: 145
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PI 007-6 VALIDATION OF ASEPTIC PROCESSES.pdf
167.12 KB, 下载次数: 137
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PI 011-3 GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED GXP ENVIRONMENTS.pdf
442.91 KB, 下载次数: 151
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PI 012-3 STERILITY TESTING.pdf
159.22 KB, 下载次数: 124
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PI 014-3 ISOLATORS USED FOR ASEPTIC PROCESSING AND STERILITY TESTING.pdf
194.6 KB, 下载次数: 132
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PI 026-2 QUALIFICATION AND TRAINING OF INSPECTORS IN THE FIELD OF HUMAN BLOOD, T.pdf
174.01 KB, 下载次数: 122
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PI 032-2 GMP ANNEX 1 REVISION 2008, INTERPRETATION OF MOST IMPORTANT CHANGES FOR.pdf
169 KB, 下载次数: 122
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PI 037-1 A RECOMMENDED MODEL FOR RISK-BASED INSPECTION PLANNING IN THE GMP ENVIRONMENT.pdf
130.96 KB, 下载次数: 121
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PI 041-1 PICS-S数据完整性指南-20210701（英文对照版）.pdf
952.88 KB, 下载次数: 155
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PI 041-1 PICS-S数据完整性指南-20210701（中英文对照版）.pdf
1.44 MB, 下载次数: 204
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PI 045-1 GUIDELINES ON THE FORMALISED RISK ASSESSMENT FOR ASCERTAINING THE APPRO.pdf
74.94 KB, 下载次数: 123
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PI 046-1 GUIDELINE ON SETTING HEALTH BASED EXPOSURE LIMITS FOR USE IN RISK IDENT.pdf
121.12 KB, 下载次数: 125
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PI 047-1 GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICE OF ACTIVE SU.pdf
138.63 KB, 下载次数: 118
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PI 054-1 How to Evaluate and Demonstrate the Effectiveness of a Pharmaceutical Q.pdf
409.81 KB, 下载次数: 132
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PICS-数据可靠性指南-2018.11（翻译稿）.pdf
1.16 MB, 下载次数: 167
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PI 002-3 QUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL INSPECTORATES.pdf
129.69 KB, 下载次数: 135
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PIC S VMP 验证主计划（中英文对照）.pdf
308.66 KB, 下载次数: 240
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