۷ι ȭ ȭ
Ǻ ѱǻ ϴ ﱹ ؿ ϱ ǰ ȭ, ǰ , Ʈ ߱ Ͽ ۷ι ȭ ȭ մϴ.
2019 3 25
ѱǻ
1.
۷ι ȭ ȭ
ﱹ ؿ ϱ ǰ ȭ, ǰ , Ʈ ߱ ؿ ȭ
Ǿǰ ǰ ȭ
( Ը) ִ 50鸸 (ڱδ 50% ̻)
* ѻ ݰ ڱδ ݾ ڱδ ѻ 50%̻ δϿ(ڱδ ݺδ Ģ )
* : 10õ(ѻ)=5õ()+5õ(ڱδ)
( ) ǰ cGMP Ǵ EU GMP WHO PQ ȹ غ
( ) Ǿǰ ǰ ü(GMP) ȭ ҿ ؿ WHO PQ( ݽɻ) ( )
- ü ȭ ҿ
- GMP ǽǻ غ ҿ( ؿ Ʈ û)
- ⱸ Ǿǰ о Ưȭ ȹ ۼ WHO PQ( ݽɻ)ȹ
(Ÿ Ưȭ) Ȱ ǻ ؿ/GPKOL Ͽ
ﱹ ѱǾǰ μ ǰ ȭ
( Ը)
- ؿ : ִ 100鸸 (ڱδ 50% ̻)
- ǰ ȭ : ִ 50鸸 (ڱδ 50% ̻)
* ѻ ݰ ڱδ ݾ ڱδ ѻ 50%̻ δϿ(ڱδ ݺδ Ģ )
* : 10õ(ѻ)=5õ()+5õ(ڱδ)
( ) ﱹ(ߵ, ߳, ƽþ)
* ƶ, , , ĥ, , Ʈ, ̽þ, ±, ʸ, ε, ߱
( ) ﱹ ϰ ϴ , ǰ ȭ ҿǴ 뿡 ( )
- ( ȭ) ϰ ϴ ѱ Ǿǰ ҿǴ
* () , Ʈʻ ҽþ Ͽ (Joint Venture)
* ( ) QC Equipment ʿ غ Ͽ ʼ , Ÿ缺 (F/S) , , , ҿ
- (ǰ ȭ) ﱹ Ͽ Ǹϰ ϴ Ǿǰ ؿǰ
* ( ) ϷǾǰ(ž, Ǿǰ, Ǿǰ ) Ǿǰ ǰ 㰡 㰡û ϴ
(Ÿ Ưȭ) Ȱ ǻ ؿ/GPKOL Ͽ
| ֿ䳻 |
ѱǾǰ μ | ⦁ ( Ը) ִ 100鸸 * ڱ()δ : ݾ() 100% ̻ Ī ʼ ⦁ ( ) ﱹ Ͽ ϰ ϴ ѱ ⦁ ( ) ﱹ ϰ ϴ 1) ѱ Ǿǰ ҿǴ 2) 㰡 Ʈʻ ҽÿ Ͽ ѱ Ǿǰ ․(Joint Venture) ϴ 쿡 ҿǴ * QC Equipment Ͽ ʿ غ Ͽ ʼ , Ÿ缺 (F/S) , , , ҿ * () (ڻ) δ |
ǰ ȭ | ⦁ ( Ը) ִ 50鸸 * ڱ()δ : ݾ() 100% ̻ Ī ʼ ⦁ ( ) ﱹ Ͽ ѱ Ǿǰ ǰ ϰ ϴ ѱ ⦁ ( ) ﱹ ǰ ؿ ǰ( FDA 㰡 ) * ϷǾǰ(ž, Ǿǰ, Ǿǰ ) Ǿǰ ǰ 㰡 㰡û ϴ * Ⱓ ǰ ϷǴ 쿡 |
2. Ⱓ
ûڰ
о ۷ι ̿ó
* ڰ
Ⱓ
üϷκ 2019 11 30ϱ
ְ ÿ ȸ Ͽ Ͽ
* ȸ 꿡 ʿ ȸ ⳻ Խų (ڼ û )
ǹ
ְ ħ ؼϿ
û ü (߰, ) ǹ
() Ⱓ ִ 3 ý Ͽ
(: 5)
̿ óұ (: 3)
* ó Ǵ ұ Ȯ ִ (, ó, ұȮμ)
* ִ 5 ʰ
3. ⼭
û Ⱓ
| Ⱓ |
⦁ ﱹ ѱǾǰ μ ǰ ȭ ⦁ Ǿǰ ǰ ȭ | 2019 1 21() 2019 2 15() |
(Ⱓ) 2019. 04. 23(ȭ) 17:00
() Ǵ 湮
- 1 纻 10
û (ѱ۹ ) /湮 ϱ E-mail(mintberry730@khidi.or.kr) ݵ
⼭
|
|
|
û | - ü ( ) * ѱǻ û ȹ û ü ۼϿ | ¶ (mintberry730@khidi.or.kr) |
սû [1] | - [ 1] û ۼ | ¶ , ./湮 10 |
ȹ [2] | - [ 2] ȹ ۼ * û ȹ պϿ |
Ÿ ⼭ | - [ 2] ȹҮ ÷μ |
ιǥ ڷ (ĿƮ ) | - û , ֿ , ȹ, ü ҽþ , ȿ ۼ * ǥڷ ppt ڿ ̸ ۺ ** ǥڷ 10 ppt usb | ¶, ǥ 10 |
湮 : (28161) ûϵ ûֽ ۻ2 187 ѱ ̿
ó
ѱǻ ̿
| ȭ | ̸ |
| 043-713-8626 | mintberry730@khidi.or.kr |
* ڼ ÷