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2��������ˎ���I(y��)���P�˜ʸśr.................................................. 9
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2.2 �����y�И˜�............................................................ 14
3. ���b�Ƅ����ˎ���I(y��)�śr................................................... 15
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3.3 GMP �J�C���PҎ(gu��)��........................................................ 19
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4.1 ���w�Ƅ�����a��ˇ����Ⱦ�{�����........................................ 20
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4.3 �����Ƅ��.............................................................. 38
5. ���b�Ƅ����ˎ���I(y��)�Uˮ�������g........................................... 40
5.1 ��ˇ��������............................................................ 40
5.2 �Y�����h.............................................................. 45
6. �˜ʵĽY���OӋ........................................................... 46
6.1 �˜ʵ��m�÷���.......................................................... 46
6.2 �˜ʵĿ�ܽY��.......................................................... 46
6.3 �˜ʵă���.............................................................. 48
6.4 ���˜��c�����F�И˜ʵ��Pϵ.............................................. 48
7. �˜�ֵ�Ĵ_��............................................................. 48
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7.2 �Uˮ�ŷŘ˜ʵĴ_��...................................................... 49
7.3 ˮ��Ⱦ���ŷ����M���Ƽ��g��ֵ............................................ 53
8�����˜��c���P�˜ʵı��^................................................... 54
9����(zh��)�б��˜ʵ�Ч�����..................................................... 57
9.1 ���w�Ƅ��.............................................................. 57
9.2 ע�䄩�................................................................ 58

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