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2004.11.29

Sm_lee@amorepacific.com

. , .

.

.

,

(, )

( )

(, , , , )

,

/ /

(QM : Quality Management)?

/ NEEDS Leading /

SEEDS

(QUALITY)

/ NEEDS Leading /

SEEDS

(QUALITY)

(QM)(QM)

PROMOTION

ED

PILOT

/

:

NEEDS

(QM)(QM)

(ISO 9001) //

(ISO 17025)

: 2004

(ISO 17025)

: 2004

(CGMP)

(CGMP)

(ISO 14001)

(ISO 14001)

(K-OHSMS 18001)

(K-OHSMS 18001)

ISO ISO

(ISO 9001)

(ISO 9001)

=> : 1 /, : 1 /

/

CGMP( Cosmetic Good Manufacturing Practice)

- -,- (,)- ,

-- -

--- - -

- - - , -,- --

--

[ , PL, ]

97% 150g(mL)

100% 150g(mL)

pH ,,

(,4%)

3.0 ~ 9.0

20ppm

10ppm

1ppm

0.2v/v%

500cfu/mL

SPF

, , , ,

90.0% ( )

,

, , , , pH,

, , , , , , , ,

,

, , , , , , , ,

QC ( Quality Control)

(,)

(,)

,

.

/

(,,)

TCR

ISO9001, CGMP

, ,

,

(Quality Assurance)(Quality Assurance)

PILOT

/

DB ()

/

( )

Seeds

/

( )

Pilot

,

Stability, Safety

- Check

- Check

- Pilot Check

- Check

- Check

- Check

((/Pilot//Pilot/))

A

A

Pilot

B

Pilot

B

C

C

K

K D

D

E

E

F

F

G

G

/

H

/

H

TEST

I

TEST

I

J

J

Pilot QC

TEST

((/Pilot//Pilot/))

1. 1. (1)(1)

-15, 0, 25,37, 40, 45,

50, Cycle

1~31. , , , , ,, , , , , , ,, pH , ()

Sun Test

5~10- 12

2. , , , , ,,, ()

0, 25, 40,45, Cycle

1~33. Rheology , Gelation, Consistency

Challenge Test 1~34.

Patch Test, 1~35.

, Test

1~36.

, , , ,

, ,(Cycle, 50)

1~37. , , , , , ,, ,

70 4 8. Press Type Powder ,

Check Check

((/Pilot//Pilot/))

1, 2 Pilot 1~29. - (, , , ) ( , , )

- Shear(, RPM, )

- - - Scale-up Match -

Check Check

Data 1~210. Review - - - - - Pilot

1. 1. (2)(2)

((/Pilot//Pilot/))

2. Pilot 2. Pilot

, , , pH

1~31.

, , , pH, , , , ,

Check Check

,

1~22.

, , ,

, Sheet,

3~53. Pilot

, , , pH, , , , ,

* Test ( , ) * , * Test * Test

* Test

: Test,

: Test, Test, Test, Test, Test

: Test, Test, Test, , , ,

Tesr

: , ,

Test

((/Pilot//Pilot/))

3. 3.

-15, 0, 25,37, 40, 45,

50, Cycle

1. Pilot 3 1

1. Pilot

2. Pilot

3.

, , , , ,

Challenge Test

5~101~8

1~3

Check Check

2. Pilot 3~12 1

3. Pilot 12~24 1

Sun Test

, , , , ,

((/Pilot//Pilot/))

. .

. . .

(Batch Reactor )

- - ()- -

- - ()-

[ ]

- - - /- - ()- -

- - - - -

- - - - -

- - - - -

: /

: /

:

(())

( , ,

, )

- : ,,- (,,)

(HPLC, UV, GC)- (AA) -

-

-, , , 600

- - , - MSDS

1)1) (() )

- : , ICID, , , EU, .

() (())

, ,,

- : ,,, - (,,)

(SPF Analyzer, IC, GC, HPLC)-

- : ,,, : , - : 30 7hr ( )

- : (,)- : ( )

- : -10, 5, 37, 45 (: cycle )- : 30 (22~24) 12hr 30 7hr

2)

/

() (())

process

- : ( )

- : SPF Analyzer, IC, GC, HPLC- : 90.0% - : , , : Retinol, Oleanolic Acid, : Arbutin, , ,

: -p-,

, , , ,

3)3) : : (() )

/

() (())

, , . 70% .

clean bench petri dish (letheen agar), (sabouraud dextrose agar) petri dish . autoclave 121, 15 40~45

petri dish incubator . 30~32 48, 25~2772 .

petri dish () count . .

.

4)4) : :

1) PLATE 2) PLATE

(, )

/

() (())

: , ,

APPEARANCE : ,

Rub-Out : , , Oily,

Afterfeel : , , ,

: , , ,

: , JET,

/

5)5) : :

() (())

6)6)

/

/

Zet No./

/

()

Lot

Lot

Lot

() (())

CGMP CGMP ::

..

, ,

. . ..

.

.

(, , , )

, , , , Data .

.

( , )

.

(())

1036598

3012500

320.000G 1 2

C05C150N4

NO

oo10 600677 A W1 3,840 C15

oo20 600687 B W1 11,200 C15

oo30 600569 C W2 3,200 C15

oo40 600555 D W1 1,920 C15

:

: 2002.10.29

1036598

3012500

320.000G 1 2

C05C150N4

NO LOT NO

oo10 600677 A W1 3,840 C15 2E+09 C07

oo20 600687 B W1 11,200 C15 C07

oo30 600569 C W2 3,200 C15 C09

oo40 600555 D W1 1,920 C15 C09

:

: 2002.10.29

BATCH : A02114

6-20021028-1-045 6006138 2002925

LOT 20020925 A LOT 1000049631 A 60,000.000G 100.000G 20020925 20020925 1000049631 #1 20020925 20020925

300ml

1.4110 1.1260

ppm

: : 20020928 :

n:1.410~1.420 2002.09.28 d:1.120~1.150 2002.09.28 2ppm 2002.09.28

3-20021025 3013211 20021025

20021025 650,000,000G 1007729 20021025 300.000G 40000049271 #1 400000000 20021025 20021025

% 0.970 cfu/g

4.6

: : 20021025 :

()

2002.10.25 d:0.965~0.975 2002.10.25PH 4.2~5.2 2002.10.25

1-20021028-1-009 110481011 20021029

300ml 2002109 1,580,000,000G 320.000G 20021028 58,031,140G 40000049271 204ea 5ea 300ml 20021028 4 #1 20021028 20021028

300ml

100.0 % 0 cfu/g

4.6

: : 20021030 :

PH

97%100cfu/g

4.2~5.2

2002.10.302002.10.302002.10.29

()

QA

EDI

* B/L, Invoice, Packing List

EDI

EDI

:

Invoice

(, ,)

(())

1. : .

.

2. :

(, 0.5%

.)

1. , C

2.

3.

4. (dl--), E

5. , A

ex) C, 2500 ,

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04.9.5 :

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(6)+

15

:

Fresh , ,EU 2005 3 .

No.

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

No.

17

18

19

20

21

22

23 Homomixer(Homogenizer)

24 pH

25

26 ()

27

28

29

/

(VOC)

(QFD)

IT

MOT

MOT

CSI

CSI

CSI

CSI

CRM

CRM

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