28 2551 1 / 7

.. 2548

(GMP )

1. / GMP 1.1 /

1.2 /

1.3 /

1 1.4 /

.. 2548

1.5 / .. 2548 4 1. 2. 3. 4. 4

1.6

2. .. 2548 /

.. 2548

- .. 2548 (. . 01) 1

- 1 - (. . 02)

1. 2. 3. ( ) 4. 5. ( ) 6. 7. 8. ( ) 1

28 2551 2 / 7

2.1 / ( . ) 2.2 / (. . 01)

3. . / GMP - - /

( 2548 http://wwwapp1.fda.moph.go.th/drug/zone_gmp/gmp_know.asp)

-

4. 4.1

/ / - /

/

- /

- - / /

/ .

28 2551 3 / 7

4.2 GMP - / - / - -

/ / 4.3

4.3.1 GMP 2 - - () - - / / -

Batch Record

- Major Defect Major Defect ... Major Defect ... / ... / ... / ...

- Major Defect / (Major Defect) .....( )... 15

4.3.2 8 check list / //

4.4 / - - -

28 2551 4 / 7

- / -

GMP /

5. 3 5.1 Major defect

5.1.1 / (Major Defect) 15 (Follow-up) /

1 1 / GMP 2

5.1.2 (Follow-up) / 1

5.1.3 (Follow-up) 5.1.3.1 .

GMP ( .) /

5.1.3.2 . GMP . /

28 2551 5 / 7

5.2 Major defect 5.1.3.1 5.1.3.2

/

/

5.3 Major defect

5.1.3.1 5.1.3.2

6. 2

7.

7.1 / . 7.2 /

8. / (. . 01)2. . GMP / . ( )

9.

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/ (. . 01)2. . 2 GMP / . ( ) 2

10. / / / .. 2548 (Major Defect)

/ 120 / (Major Defect)

11. / / . (Follow-up) / ( )

12. / 12.1 /

12.2

.. 2548 (Major Defect)

12.3

28 2551 7 / 7

90 /

13. - /

.. 2548 - -

/ ( ASEAN GMP ) / (GMP-Guidelines for the Manufacture of Herbal Medicinal Products)