pic/s gmp - trade and industry department
TRANSCRIPT
TXT_3.inddPDA
The Pharmaceutical Distribution Association of Hong Kong
/
PIC/S GMP
78
2015
7
8
2.15
IN THIS AREA
10
3.1
3.2
HEPA
5S
3. SEISO
5. SHITSUKE
4. SEIKETSU
18
3.18
Verifies that a process / piece of equipment performs as it is intended to in the manufacturing process and produces product (in process or final) meeting predetermined specifications.
A process designed to supply the documented evidence that a piece of equipment operates as it is intended through all anticipated operational ranges.
A process used to document that the piece of equipment was supplied and installed properly and that appropriate utilities, i.e., electrical, steam, gas, etc. are available to operate the equipment according to the manufacturers specifications.
Installation Qualification (IQ)
Operational Qualification (OQ)
23
2.14
2.14
3.5
3.13
7
3.5
3.13
30
( )
( )
33
5.20
5.20
/
6.4
/
6.4
7.7
)
7.7
)
9.3
9.3
44
,,
(),
,,
(),
________________________________________________________________________ "5
GMP • • • / • • •
1.2 • • •
________________________________________________________________________
________________________________________________________________________ "5
GMP • • • / • • •
1.2 • • •
48
1.4k /
1.4l /
/ 1.5
(PIC/S)20 http://www.picscheme.org/
1.4k /
1.4l /
/ 1.5
(PIC/S)20 http://www.picscheme.org/
2.72.8 /
a) • GMP1 • GMP6 GMP
b) • GMP2 • GMP1 GMP
• 5 2
• 5 2/ E#
•
# 2007 E 2007 2
(http:// www.hkcaavq.edu.hk/)
2.9 2.10
________________________________________________________________________
2.72.8 /
a) • GMP1 • GMP6 GMP
b) • GMP2 • GMP1 GMP
• 5 2
• 5 2/ E#
•
# 2007 E 2007 2
(http:// www.hkcaavq.edu.hk/)
2.9 2.10
50
3.7
•
3.9 3.10
300
17-25oC 65%
EN779:2012G4
________________________________________________________________________
3.7
•
3.9 3.10
300
17-25oC 65%
EN779:2012G4
51
• HEPA
• M6 AHUG4
• 6
12-24
• HEPA
• M6 AHUG4
• 6
12-24
3
1 1
4 GMP 2GMP/
SOPs
________________________________________________________________________
3
1 1
4 GMP 2GMP/
SOPs
________________________________________________________________________
4.13
4.26
5.3
5.9b, 5.14
________________________________________________________________________
3
1 1
4 GMP 2GMP/
SOPs
________________________________________________________________________
3
1 1
4 GMP 2GMP/
SOPs
________________________________________________________________________
3
1 1
4 GMP 2GMP/
SOPs
/
53
4.13
4.26
5.3
5.9b, 5.14
________________________________________________________________________
4.13
4.26
5.3
5.9b, 5.14
54
/
(PIC/S)8 http://www.picscheme.org/
________________________________________________________________________
/
(PIC/S)8 http://www.picscheme.org/
55
5.20
________________________________________________________________________
5.20
56
/
1530
5.25
6.4
6.5 ISO 2859
________________________________________________________________________
/
1530
5.25
6.4
6.5 ISO 2859
57
2
(PIC/S)19 http://www.picscheme.org/
6.9
________________________________________________________________________
2
(PIC/S)19 http://www.picscheme.org/
6.9
58
1 (b)(i) (b)(ii) (b)(iii)(iv)
(PIC/S)19 http://www.picscheme.org/
9 PIC/S
12
________________________________________________________________________
1 (b)(i) (b)(ii) (b)(iii)(iv)
(PIC/S)19 http://www.picscheme.org/
9 PIC/S
12
59
The Pharmaceutical Distribution Association of Hong Kong
/
PIC/S GMP
78
2015
7
8
2.15
IN THIS AREA
10
3.1
3.2
HEPA
5S
3. SEISO
5. SHITSUKE
4. SEIKETSU
18
3.18
Verifies that a process / piece of equipment performs as it is intended to in the manufacturing process and produces product (in process or final) meeting predetermined specifications.
A process designed to supply the documented evidence that a piece of equipment operates as it is intended through all anticipated operational ranges.
A process used to document that the piece of equipment was supplied and installed properly and that appropriate utilities, i.e., electrical, steam, gas, etc. are available to operate the equipment according to the manufacturers specifications.
Installation Qualification (IQ)
Operational Qualification (OQ)
23
2.14
2.14
3.5
3.13
7
3.5
3.13
30
( )
( )
33
5.20
5.20
/
6.4
/
6.4
7.7
)
7.7
)
9.3
9.3
44
,,
(),
,,
(),
________________________________________________________________________ "5
GMP • • • / • • •
1.2 • • •
________________________________________________________________________
________________________________________________________________________ "5
GMP • • • / • • •
1.2 • • •
48
1.4k /
1.4l /
/ 1.5
(PIC/S)20 http://www.picscheme.org/
1.4k /
1.4l /
/ 1.5
(PIC/S)20 http://www.picscheme.org/
2.72.8 /
a) • GMP1 • GMP6 GMP
b) • GMP2 • GMP1 GMP
• 5 2
• 5 2/ E#
•
# 2007 E 2007 2
(http:// www.hkcaavq.edu.hk/)
2.9 2.10
________________________________________________________________________
2.72.8 /
a) • GMP1 • GMP6 GMP
b) • GMP2 • GMP1 GMP
• 5 2
• 5 2/ E#
•
# 2007 E 2007 2
(http:// www.hkcaavq.edu.hk/)
2.9 2.10
50
3.7
•
3.9 3.10
300
17-25oC 65%
EN779:2012G4
________________________________________________________________________
3.7
•
3.9 3.10
300
17-25oC 65%
EN779:2012G4
51
• HEPA
• M6 AHUG4
• 6
12-24
• HEPA
• M6 AHUG4
• 6
12-24
3
1 1
4 GMP 2GMP/
SOPs
________________________________________________________________________
3
1 1
4 GMP 2GMP/
SOPs
________________________________________________________________________
4.13
4.26
5.3
5.9b, 5.14
________________________________________________________________________
3
1 1
4 GMP 2GMP/
SOPs
________________________________________________________________________
3
1 1
4 GMP 2GMP/
SOPs
________________________________________________________________________
3
1 1
4 GMP 2GMP/
SOPs
/
53
4.13
4.26
5.3
5.9b, 5.14
________________________________________________________________________
4.13
4.26
5.3
5.9b, 5.14
54
/
(PIC/S)8 http://www.picscheme.org/
________________________________________________________________________
/
(PIC/S)8 http://www.picscheme.org/
55
5.20
________________________________________________________________________
5.20
56
/
1530
5.25
6.4
6.5 ISO 2859
________________________________________________________________________
/
1530
5.25
6.4
6.5 ISO 2859
57
2
(PIC/S)19 http://www.picscheme.org/
6.9
________________________________________________________________________
2
(PIC/S)19 http://www.picscheme.org/
6.9
58
1 (b)(i) (b)(ii) (b)(iii)(iv)
(PIC/S)19 http://www.picscheme.org/
9 PIC/S
12
________________________________________________________________________
1 (b)(i) (b)(ii) (b)(iii)(iv)
(PIC/S)19 http://www.picscheme.org/
9 PIC/S
12
59