-
????
??
??? ??? ???? Validation? ?? ???? ??? ?? ?????
1. ? ?
2. validation? ??
3. GMP??? VALIDATION??
1) WHO-GMP
2) FDA-CGMP
3) EU-GMP
4) ?? GMP
4. VALIDATION? ???
5. VALIDATION? ??
1) ?? validation
2) ??? validation
3) ??? validation
4) ?? validation
5) ??????? validation
6. VALIDATION? ????¡¤??
7. VALIDATION? ????
8. VALIDATION? ????
9. VALIDATION? ???
Validation??? (??No. )
Validation????? (??No. )
Validation????? (??No. )
Calibration Data Sheet (??No. )????
1. ? ?
?? GMP?? validation? ???? ???? ??. ??? "validation? ?????"? ??? ??? ? ? ??? ????? ?? ??. Validation? ?? ??? ??? ??? ???? ?? 4? 4(???????GMP)? "??"?? ?? ??, ??? ?? ??? "¥Ð¥ê¥Ç-¥·¥ç¥ó"(????)??, ??? "??(òž×C)", ????? "??(´_Ч)"?? ??? ???? ??.
FDA??? GMP??? ??? ? ? ?? validation ???? ????? ?? ???? ???? ??? ??? ??? ??? ??? ?? ? ??? ????. ? ??? ???? ??? ???? ?? GMP? ??? validation? ??? ????, "validation? ?? GMP? ??(É°ÉÏ)? ??(˜Çéw)? ??"? ? ?? validation? GMP? ???? ????. ??? WHO ? ????? ??? ??? ???? GMP?? validation? ??????? ??? ??? ?? GMP? ???? ?? ???.
Validation? ??? ?? GMP? WHO? 1969?, FDA? 1963?, ??? 1974?? ??¡¤??? ???? GMP? validation??? ???? ? ? validation??? ???? GMP? ?????.
??? ??? ??? ?? validation??? ???? ????? ???? ??.
WHO: Good Manufacturing Practices: Guidelines on the Validation of Manufacturing Processes (1996)
FDA: Guideline on General Principles of Process Validation (1987)
? ?: ¥Ð¥ê¥Ç-¥·¥ç¥ó»ùœÊ (1995)
GMP? ??? ???? ???, ?? ?? ?? GMP??????(Mutual Recognition Agreement, MRA)? ???? ???? validation? ???? GMP???? ????? ??. ?? ?? ?? ??? ???? GMP? ??? ???? ????? ? ???.????
¡¤ ????
-
????
Ai ??? ??? ??? ??? ????, ??? ?? ???? ??? ????????. ??? ????? ?? ??? ?????. ????? ?????! -
??????? ??? ??? ???
? ?????
-
??? ?? ? ??? ???? ??? ?????? ???? ???, ?? ?? ? ??? ???? ?? ?? ??? ?? ????? ????.
?? ? ??? ??? ??? ??, ?? ?????? ???? ????.
?????, ???? ? ?? ?? ?? ? ????? ????? ????? ??? ??? ????. -
?????? ???? ??? ??? ???? ???? ??? ???? ???, ??? 4?? ???? ??? ? ?????? ????.
???? ???? ??? ?? ??? ?? ?? ??? ??? ????? ??? ?? ??? ????? ?? ?????? ?? ???? ?? ?? ?? ??? 70% ?? ??? ???? ?? (???? ??? ? ?? ?? ???) ???? ?? ???, ????, ??, ?? ?? ??? ??? ?? ??? ??? ?? ??? ??? ???? ?? ??
?? ??? ??? ??? ???!
-
[????]validation ?? (??????)
23???
Validation ????? ?? ???? ?? ???? ? ??? ?????, ??? ?? ???, ??? ?? ??? ??? ????? ??? ? ??? ?? ???, ????? ???? ???? ? ???? WHO, FDA, EU, ?? ??? GMP ??? validation ??? ?? ?, ??? ??? ?? ??? GMP ??.. -
????????????
17???
?? 1. GMP?? ??: ????????? 2004? ¡°????????????¡± ?? ¡°???????? ?? ? ??????¡± ???? ??????? ?? ?? ?22?, ?? ? ???? ?26? ? ?27?? ??? ????, ??? ??????? ?????? ???? ?? ??. ????????????(GMP)?? ??? ??? ? ?? ??.. -
??? ???
5???
1. GMP (1) Good Manufacturing Practice (GMP) ??? GMP? ?? ??? ??? ?????? ???? ?? ????? ???? ????? ???? ??? ?????? ??, ??, ??? ?????? ? ??? ?? ??? ??? ??? ?? ????? ???? ??? ???.GMP? Good Manufac..
-
????
12???
????? ???? ??? ???? ? ???? ?? ???? ????? ?????. ????, ???? ?? ???? ???? ??? ???. ????? ?? ??? ??? ??? ??? ?? ? ??. ???? ???? ??? ????? ? ??? ??? ????? ??? ??? ??(solar thermal electricity)??, ???(pho..
-
GMPs???? ??
4???
: ??? GMPs? ???? ???? ??????? ??? ???? ?? ?? GMPs? ??? ???? ??? ???, ?? ???? ????? meaningful GMP reminder?? ?? ????? ?? ???? training program ? ???? ??. GMPs? ????? ?? ,?????? ??? ???? ??, ?? ????..
?? ??? ????? EasyAI
¡°EasyAI ? ??? ?? ??? ???? ?? ? ????"
