菌体库验证方案 7.8

1 15
G2015-SY-SP-UTIL-OQ/PQ-0801
2014 07 23

2 15

2014 07 23
GMP

3 15

2014 07 23
1 2012.05 G2012-SY-SP-UTIL-OQ-0801
2 2013.06 G2013-SY-SP-UTIL-OQ-0801
3 2014.06 G2014-SY-SP-UTIL-OQ-0801
4 2015.07 G2015-SY-SP-UTIL-OQ-0801

4 15

2014 07 23
1............................................................................................................................................6
2............................................................................................................................................6
3............................................................................................................................................6
3.1 ...............................................................................................................6
3.2 ....................................................................................................................................6
3.3 ............................................................................................................................6
3.4 ...................................................................................................7
4................................................................................................................................7
5........................................................................................................................................7
6....................................................................................................................................7
6.1 ................................................................................................................................7
6.2 ................................................................................................................................8
7....................................................................................................................................8
7.1 ........................................................................................................................................8
7.2 ........................................................................................................................................8
7.3 ............................................................................................................................8
7.4 ................................................................................................................................8
8....................................................................................................................................9
8.1 ........................................................................................................................................9
8.2 ........................................................................................................................................9
8.3 ............................................................................................................................9
8.4 ........................................................................................................................9
9.....................................................................................................10
9.1 ......................................................................................................................................10
9.2 ......................................................................................................................................10

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2014 07 23
9.3 ..........................................................................................................................11
10............................................................................................................................12
11................................................................................................................................12
12...................................................................................................................12
13........................................................................................................................................13
13.1 ....................................................................................................................13
13.2 ............................................................................................................................13

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2014 07 23
1.
2.
3.
3.1
3.1.1
3.1.2
3.1.3
3.1.4
3.1.5
3.1.6
3.1.7
3.1.8
3.2
3.2.1
3.2.2
3.2.3
3.2.4
3.2.5
3.3
3.3.1 GMP
3.3.2
3.3.3 SOP
3.3.4

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2014 07 23
3.4

SOP

4.
2010 201131
5.
OQ
PQ
GMP
6.
6.1

8 15

2014 07 23
-204-19-22
-17-23
6.2
7.
7.1
7.2
7.3
7.4

9 15

2014 07 23
8.
8.1
8.2
8.3
8.4
8.4
8.4

10 15

2014 07 23
10
11
12
9.
9.1
-204
9.2

11 15

2014 07 23
48
48 5 96
9.3
-204 6
9.4 9
9

1
2
3
4
5
6
7
8
9
10
11
12

12 15

2014 07 23
-204 6
10.
11.
[SMP08-211/X]

13 15

2014 07 23
12.
[SMP08-210/X]
13.
13.1
X/YX
13.2
1 2 3
1

4 5
3

6 7 8

9 10 11
2

4 12
1
10
4 7
118 2 3 6 59
12 1

菌体库验证方案 7.8

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菌体库验证方案 7.8

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