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1.3 ��(bi��o)��(zh��n)��ӆ�ķ��ɷ�Ҏ(gu��).................................... 6
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2.2 �����y��(bi��o)��(zh��n)............................................................ 14
3. ���b�Ƅ����ˎ���I(y��)�śr................................................... 15
3.1 ���b�Ƅ��ˎ�ﶨ�x�����................................................ 15
3.2 ���b�Ƅ����ˎ���I(y��)�śr.................................................. 16
3.3 GMP �J(r��n)�C���P(gu��n)Ҏ(gu��)��........................................................ 19
4 �����b�Ƅ�����a(ch��n)��ˇ����Ⱦ�{(di��o)�����........................................ 20
4.1 ���w�Ƅ�����a(ch��n)��ˇ����Ⱦ�{(di��o)�����........................................ 20
4.2 ע�䄩����a(ch��n)��ˇ����Ⱦ�{(di��o)�����.......................................... 28
4.3 �����Ƅ��.............................................................. 38
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5.2 �Y(ji��)�����h.............................................................. 45
6. ��(bi��o)��(zh��n)�ĽY(ji��)��(g��u)�O(sh��)Ӌ........................................................... 46
6.1 ��(bi��o)��(zh��n)���m�÷���.......................................................... 46
6.2 ��(bi��o)��(zh��n)�Ŀ�ܽY(ji��)��(g��u).......................................................... 46
6.3 ��(bi��o)��(zh��n)�ă�(n��i)��.............................................................. 48
6.4 ����(bi��o)��(zh��n)�c�����F(xi��n)�И�(bi��o)��(zh��n)���P(gu��n)ϵ.............................................. 48
7. ��(bi��o)��(zh��n)ֵ�Ĵ_��............................................................. 48
7.1 ��Ⱦ���ŷſ���ָ��(bi��o)���x��................................................ 48
7.2 �Uˮ�ŷŘ�(bi��o)��(zh��n)�Ĵ_��...................................................... 49
7.3 ˮ��Ⱦ���ŷ����M(j��n)���Ƽ��g(sh��)��ֵ............................................ 53
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9����(zh��)���(bi��o)��(zh��n)�������..................................................... 57
9.1 ���w�Ƅ��.............................................................. 57
9.2 ע�䄩�................................................................ 58

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