??????:?????????????????

1
??????????
???
2
? ????????? ? ?????????
3
?????????
4
??????????????????????? ??????????,??,??,??,??
,??? ???????????? ????,????,????
????????? ?????,???,HVAC? ??????????????
??????????
5
????GMP???? ?31????????????
?32?????????????,??????????? ?34?????????
?35??????????????,??????
6
?????????????????(1)?????????????(2)????????????
????,?????????????(3)???????????????????GMP??,??G
MP????
7
??????
8
?????????? ????????(URS)
??????(FS)?????(DS) ???????
????????(FAT)???????(SAT)???
9
1. ????????URS(1) URS?????????????,??????????????
???,???????????(2) URS?????????????(3)
URS????????,????,????,GMP??,????,????,?????? (4)
??????,????????,??????,?????????
10
URS??SMART??SSpecification,??????????M
Measurable, ????????????????AAchievable,????????
??,???????RRepeat,???????????????TTraceability
,???????????????????
11
???????GMP????URS?????,?????????
12
?? ????
1 ??(??) ?900mm24001800mm
2 ????????2.5??,??9???
3 ????? ??316L,Ralt0.6µm,??304
4 ????????????(PTFE)???????(EPDM)
5 ????????
6 ??????????? (TIG)
7 ?????0.22um???(???)
8 2?HMI????
9 PLC??
10 ???GMP ???????
11 ????????????
13
12 6????,???
13 ????,?????
14 ???????
15 ?????????,??FDA????????
16 ?? ?????
17 ???????????
18 ?????????????
19 ?? ?????,?????
20 ????50?????
21 ????
22 ???? ????1?
23 ????1.3kpa/10??
24 121?,18??,???6log
25 ????
14
2. ??????(FS)?????(DS)??????,????????????????(FS)
?????(DS)???????????,??????????URS
15
3. ???????(1) ??????????,?????????? (2)
??????????,????????(3) ????????,ISO9000??,???????
?(4) ????,???????(5) ????,???????????,?????????
?????????????
16
4. ??????(FAT)???????(SAT)???????????FAT,??SAT?
17
?V????????????????
18
????????? GMP??? ???????????
???GMP????? ?????????????????? ??????????
???????????
19
???????? ??????????????????????????
???????? ?????????? ????
20
?????????
21
???? ??????? ??????? ??????????
????????? QC QA
22
GMP???? ?3?????(???????????,??????????,???????
??????) ?4??????????????????(??????????,???,?GM
P?????????)
23
GMP???? ?5???????????????(??????????,???,?????
??????????) ?6?????????????????(???????,???????
??????)
24
?????????(??) ??????(????????????8?????????GMP?
????) ????(????????????5?????????GMP?????)
25
?????????(??) ????(????????,??????,5?????)
???????(????????,??????,5?????)
26
?????????(??) ???????(????????,?????,????????
???) QC (????????,?????????????)
27
?????????(??) QA??????,??
??????????,??QA?QC??????,???????????
?????????,???,??????
28
?????????(??) ?????????????,???????QA????,???
??????,?????????? ??????????????,????,??
29
?????????? ??????????????????????????????
????????????,??????,?????????
?????????,??????????????????
????,??????????,????