行业质量体系在药品CGMP法规方面的指导原则(中文)
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CGMP
CDER
CBER
CVM
ORA
2006 9
CGMP
CGMP
HFD-240
5600
20857
301-827-4573
http://www.fda.gov/cder/guidance/index.htm
HFM-40
1401
20852-1448 http://www.fda.gov/cber/guidelines.
htm.800-835-4709 301-827-180
HFV-12
7519 2085
301-827-380
http://www.fda.gov/cvm/guidance/published.html
CDER
CBER
CVMORA
2006 9 CGMP
Contains Nonbinding Recommendations
. ....................................................................................................................................... 1
II. ............................................................................................................................ 1
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C. .........................................................................................................................................................3
D. .............................................................................................................................................4
III. CGMPS ........................................................................................... 4
A. ......................................................................................................................................................................4
B. .............................................................................................................................4
C. .....................................................................................................................................................5
D. CAPA...............................................................................................................................5
E. .............................................................................................................................................................5
F. .............................................................................................................................................................5
G. ..................................................................................................................................................6
IV. ....................................................................................................................... 8
A. .............................................................................................................................................................8
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2. ............................................................................................................................................................9
3. .......................................................................................................................9
4. .....................................................................................................................................10
5. ...........................................................................................................................................................10
B. ...................................................................................................................................................................12
1. ...........................................................................................................................................................12
2. ...........................................................................................................................................................13
3. ........................................................................................................................................................13
4. ..................................................................................................................................................14
C. ..................................................................................................................................................................15
1. ..........................................................................................................................15
2. ..........................................................................................................................................................16
3. .............................................................................................................................................17
4. ...................................................................................................................................................19
D. ............................................................................................................................................................21
1. ......................................................................................................................................21
2. ....................................................................................................................................................21
3. ..................................................................................................................................................22
4. ............................................................................................................................................................22
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作者：冒牌货
分类：专业资料
价格：150质量币
属性：32 页
大小：6.42MB
格式：PDF
时间：2025-12-04
