无菌检验及方法验证 [Compatibility Mode]

2008.5

/, GMP

.

,

"c":

Sterility is a very exacting procedure.--------USP31.

¡-t he per sonnel be pr oper l y t r ai ned an qual i f i ed--------USP30

SOP

,, .

"c":

"c":

-/

-

,, ,

35

100cfu

(

)

(K)

35C45CSampling

Test methodology Media

Incubation period

Negative test controls

Positive test controls,,,

,

,

0.45m50mm

1000ml5x200ml

USP30EP5.4Under aseptic conditions--------USP30/EP5.4 monitor regularly by appropriate sampling/ carrying out appropriate controls--------USP30

monitor regularly by appropriate controls(such as those indicated in the approprite European Community Directives and associated guidance documents on GMP--------EP5.4

/

: TSB FTM

RTU/

SOP

pH

FTM

1/2

1/3100

20(G-,G+,,,

)

RTU

100CFU,

3,5

,

,SOP

,

5FTM

TSB

--

14,5 -:

:

:,

:, :,,

SOP

COA

MSTHEAD01

Sterisure

:ChP 23-28,30-35

USP/EP20-25,30-35

,

,

14

7EP

,

----

,

a)

b)

c)

d)

-PH

GMP

1.

2.

3.

4.SOP GMP

5.EHS

IQ/OQ/PQ SOP GMP-PVDF

-

Autoclave Autoclave