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GMP ʱް
 
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1 2019-04-17~2019-04-19 40 DZ ŸƮ ķ۽ ÷
' GMP ʱް
' ѱ̿ȸ
μ ȭ ̸
̿ī ̿ī 031-628-0017 ojbly@koreabio.org

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̿ȸ Ͽ Կ , ǰ, , Ͽ ̸ ݿ 䱸Ǵ GMP ɷ

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- Ǿǰ
- ̱ FDA
- GMP ü
- HEPA filter Test

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- "HRD-net" App ġ ID( ʼ)
- ʱ⵵ οǰ(, )
ذ뵿 ħ پ ȸ ϱ 3 ̻ ο û , ȸ ش ο .

ð

-

GMP ʱ

20

1

Ǿǰ ܰ迡 GMP

Ǿǰ GMP Ǿǰ

(뱸÷÷Ƿ )

3

ܰ GMP, Chemical Ǿǰ Biosmilar Chracterization Specification( )

2

ӻ Ǿǰ GMP( )

2

2

Qualification Validation

Corrective Action & Preventive Action(CAPA) Root Cause Analysis(GIS 迵 ǥ)

3

Process Validation, Computer System Validation

(ѵǰ)

2

PIC/S , հ 븮̼

(ġƮ â ǥ)

2

3

ֽ GMP

Isolator ̿ ֻ ( )

3

WFI Qualification, Monitoring( )

2

QbD(Quality by Design) ǰ ( )

2


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