Professional Documents
Culture Documents
Fekra - Pharma Third Edition
Fekra - Pharma Third Edition
11
) Lot Release (
14
15
" "
- - - 2014
2 15
" ..
...
... ..
.. "
...
...
... ...
......
egyptianmoh@yahoo.com
..........
- - - 2014
3 15
" "
" "
.
"
"
.
1
) (
:
.1
.2/
.3
:
"
"%100
.
Regulated Industry
- - - 2014
4 15
)
(
Corrective
Preventive
.
" Death
"Elixir
107
2012 100
- - - 2014
/ Recall
.
/ Product
:Recall
)
/ /
(Mix-Up
.
) (
" "
.
:
5 15
.1
) (
/
.
Recall
.4
"
"Voluntary Recall
)
(.
.2
.5
/
"".
.
.3 .6
) (
/
)(.
- - - 2014
6 15
) (
/
.
.7
" "
.
)
... (
540 2007 .
- - - 2014
/
.
)
(
.
7 15
27 2014
2
31 2014
.leid@who.int
:
"
:
.1
Voluntary Recall
A505803
A506076
Mix-up
- - - 2014
8 15
)(
.
.2
.
.3
:
Voluntary
Recall
)(
)(
Batch Recall
)(
Batch Recall
.
.4
.
.5
- - - 2014
9 15
....
2013
"
Drug Quality and Security
"2Act
)
(
Drug Compounding
Unique Product Identifier
)(
)
.(2017
""
.
"" :
....
"
"
391 2012
.
.
- - - 2014
10 15
) Lot Release (
:
.1
1
"
!"
"
!" "
" "
!
!"
.
- - - 2014
11 15
) Lot Release (
"
"Inherent Variability
.
Consistency
Process Validation
.
- - - 2014
)
(
)
( )
(!
/
12 15
) Lot Release (
US/FDA
.
Batch Release
Certificate
Notice
.of Non-Compliance
"
"Summary Protocol
- - - 2014
/
.
"
!
!"
.
13 15
" "
" "
!Quotations
The
three
great
essentials to achieve
anything worthwhile are,
first, hard work; second,
stick-to-itiveness; third,
common sense.
""Thomas Edison
I'm a greater believer in
luck, and I find the harder
I work the more I have of
it
""Thomas Jefferson
""Vince Lombardi
" "
- - - 2014
14 15
" "
" "
:
.1
.2
.3
/
1
.7
14
.4
.5
)(egyptianmoh@yahoo.com
Microsoft Word
doc/ docx
.8
.9
/
.10
Peer Review
.6
- - - 2014
15 15