If you can't read please download the document
Upload
lykhue
View
247
Download
5
Embed Size (px)
Citation preview
FDAPIC/S GMP
2015GMP
1
1. 2. ICH Q11
3. GDP
FDA
2
3
PIC/S GMP EU GMP
ICH Q8~Q11
PIC/S GMP. GMP/GQPGMPcGMP
GMP)GDPICH QPIC/S GMP
ICH Q7 PIC/S GMP
Part II
GMP GDP
1. FDA 2. ICH Q11
3. GDP
FDA
4
5
OTC
OTC
1985 5. 1999FDA 2003KFDAMFDS 2012EMA 20155FDA
2013PIC/S 20155FDA
6
7
2012 2013 2014 2015
ICHQ7EMA PIC/S GMP part IPartII
SOP
cGMP
5 FDA
GMP PIC/S GMPSOP
2013.6 GMP
cGMP
5 FDA
2012.2 PIC/S GMP
2013.3 PIC/S GMP
2014.7 PIC/S
2013.12 GMP
2013.8 GMP
FDA
8
2014 2015 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7
FDA NDA PAI
(13/)
FDA
()
Mock
QP
GAP
1. FDA 2. ICH Q11
3. GDP
FDA
9
ICH Q7GMPPIC/S
GMP Part II
2012PIC/S GMPPart IPart I
FDAcGMP
ICH Q11
10
PIC/S GMP
11
SOP. PIC/S GMP Part II 10.23
Part I 1.1 viii
Part I 9.2
SOP GMP
SOP
cGMP
12
211.34
GMP.
cGMP
13
211.208
ICH Q11 QRM
.
. . . 14
1. FDA 2. ICH Q11
3. GDP
FDA
15
PIC/S GMPSOP.
2013 GMPPIC/S GMP. cGMP.
FDAGDP.
16
17
Part I 3.6
18
ICH Q9
OEB OEL
EC
URS
DQURS
19
OE
OEB API OEB 1 10gm3 API OEB10100gm3 (OEL) API OEL 1gm3 API OEL 10gm3
COSHH Essentials
HEPA HEPA HEPA
W/D 50Pa10Pa
BI/BO
BI/BO
MG MG
20
3
.
21
SMEPACISPE ()
1. PAO.
22
1. FDA 2. ICH Q11
3. GDP
FDA
23
GMP
24
H25.12.2 3579
PIC/S GMPH26.6.13 .
. QTPPCQA.
//
CHT,DHT
PIC/S GMPcGMP
25
PIC/S GMP Part I 5.65.
cGMP 211.204
cGMP 211.208
cGMP
26
cGMP1cGMP
211.25 (a) cGMPcGMP
211.196
1. FDA 2. ICH Q11
3. GDP
FDA
27
GDP
28
GDP
.
.
ADAP, Delivered at Place
GDP
29
A / GDP
PIC/S GDPWHO-GDP, EU-GDP
. TAPA. . . . . .
End use letter, USDA statement, COA, COC, Statement of release, Animal product exposure, BSE/TSE statement
30
20
8 . .
TempSure1051)
1. 2USDAFDA.
17.5hr
30.5hr
18.5hr
12hr
1.5hr 2)
1. FDA 2. ICH Q11
3. GDP
FDA
31
FDA
Form483
CHT
. ExcelQACSV
.
32
Chemistry/Engineering) 2015/5/115/15 2015/5/185/22
FDA . . .
/ /
33
FDA
34
. . . PQS. SOP.
4025GMP PMDA
and/or
PV
fate mapping
35
FDAPIC/S GMPFDAPIC/S GMPcGMPcGMP ICH Q11 GMPPIC/S GMPcGMPcGMPGDPGDPFDAFDAFDA