1、0 GMP L 2CPEC g p =x I0 GMP$0 $ = B M SE ? u0 3 5 ?S= B M SE ? 0 3 5 ?Sv1 p L= f vb v b A $ A $ $ L 2 L $ L 2 L $0 GMP$0 $ E c EH =c a 3 c ! c ! c ! c Bc 3 c c c q c 35 Ec e Ec e EBc g r E=c 1_K0 S5 1 pK0 S5 1 p 2013 M 5 6 z 7Sp4y K J 0 S5 J 0 S b uF f J UL aE p d J UL aE p dcSK h 3a j0 =a u0 =aa #
2、8r B / J Y# J%h . 8r B/ B/ =/ % / 2F B ?p ?p / E J J%h 8r B/ f b J UL aE p d J UL aE p d f B 3ag r-= E = 3ag r- E = E J S J v 3ag r HW 3ag r- E = E 8 J 3 ag r- E = E B M =;y J 3 EUL sV) Y) f f J UL aE p d J UL aE p d J S5 3 SE1T 3 o ? 3v J Y#/ T H J S5 L M Yq L a _ L a_f L Yq L _ L _f Lab: r ULL ULG
3、v) ?L)b J S5 3SE1T o J S5L - ? ULGv ULL)bV ? 0L V ? 0L 3g rL0L 3g r 0L dELBZE L BZE L V BZE L v3 Y#L gbBL V gbBL3g r L 3g r L L0 0 1“ 0 0 1“ SS 0o c 0 0 4 4 a3 #B353 #B35 3 Vp aVp3 Vp Vp Y3 B 3 Vp 3 3 S Vp B Vp B Vp Vp2010 GMP L 2f , 96I 2138: 1. ! GMP L 2161 2 b“d GMP L 2 194 . L 2 3. g%84 GMP L 23
4、24 4. L i e“d GMP L 2150 5 “d GMP L 2 136 . “d L 2 6. )4 GMP L 2499 7. “d GMP L 275 8. 0 GMP L 2449 9. 5 8“ GMP L 2150b0 GMP L 20 L 2 2005 M S0“v s=1 M s=1 Ib 480: 363 Ecb aq5 aF5 a a ! a !a a 3aa 35 a 5 a g r lag Q 1_ GMP ! c a1_ a ! a c0 GMP L 20 L 2 5FI 5FI FFI I I0 GMP L 2T0 L 2T ? ? u 5 8“ :0 G
5、MP 2 vSE J 0 S5 5 8“ 0 2 SE J 0 S5 0 5 I hu0 3 5 ?S2010 Mv1 p GMP 5 8“1p 8 Ll I1S= 2 5 8 p 8 Ll a“ B 0 3 5 8“ b 5 8“ :0 GMP 2 5 8“ 0 2 1 - 2 5 8“ 3 LC1 4 1 5 B5 6 5 “dq 5 “dq ID 1oMV1oMV 5 8“ :0 GMP 2 5 8“ 0 2 4 1 1 4.1 M5 4.1.1 l 4.1.2 aS 4.1.3 s 4.1.4 4.1.5 3M 4.1.6 l 4.2 5 421l 4.2.1 l 4.2.2 $ 4.
6、2.3 S 4.2.4 3 4.2.5 ) 4.2.6 HK 4.2.7 n CAPA“d 4.2.8 “d t s 5 8“ :0 GMP 2 5 8“ 0 2 4.3 $ 44g 4.4 g 4.4.1 g s 4.4.2 3 4.4.3 g 5 4.4.4 HK? 445g $ t s4.4.5 g $ t s 4.5 z 4.5.1 zls) 4.5.2 3 4.5.3 z 461_ s_ 4.6 1_ s_ 4.6.1 1_ 4.6.2 s_ 4.7 n n 4.7.1 CAPA“d “d !9 4.7.2 CAPA“d !9 4.7.3 CAPA = 4.7.4 CAPA“dd9s
7、# 6.3.6 : cGMP_ 2Y5 (2011 M 3 1 L )_ 2Y5 M SE J 0 S5 S aSE J 0 S5 SE J 0 S5 S SE J 0 S5 0 48: 4.53: 3Y 5 Y 5 ! ! 3 q 35 5 g r l Qg Qg 1_H H *0401 5 3 5 3 D0M1v i 0 3 5 ?S L 3b 1.50 3 3 H ? Llb sY / S s 3 0/ 0 3 1 S b1 S 2.H 1 pM V 0302H1 pM1 b 3.5 3 5 3 B M 0 3 5 Ll 5 Ll b r J 3 , 2 r J 3 , 2 =a , =
8、 B , 1 py b a 3 ? a 8“a aM1 = , SEE pE?aS?S 1 pb = V , y PV , V= V , y PV , V b a 3 Pa_ f a ) Z ,b 5 y 8 N b 5 y 8 N a? a/ a qZ T i |b C , 7ZC , 3 ? 3V eZ , a 3V eZ , b r J 3 , 2 r J 3 , 2 a ,1 , = P + M ,1b Bq , 1. vaE 3 q 5 8“q 2. 5 8“q 3. 3 3em 4. ?a a 1_ r_b = l_= l_ 3 / 1 p l_1 p Q4r_ b C , C , 3 y C ,1# ,5 3a a 3Va%iHqa 5 Y y C , b0 GMP L 2Hq0 E pE?$E pE?$ g / #/ # C L$0 1 p 0 1 p0 GMP L 2yp0 L 2yp I0 GMP 2 I0 2 0 GMP 2 p0 in p0 in p0 ins k s k w0 5 t 0 5 t w DMFw =s , 0 3 3 0 3 3 T ,9 SES gS SES gS
