行业质量体系在药品CGMP法规方面的指导原则(中文)

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󶩰󳯂 CGMP 󵏖󷃅󵶅󷐩󷣐󳙔󶏼󴲺

󵏖󶽍󳔛󴨈󳩘

󶚏󳷾󳩬󵰠󳔏󳡭󳘘󴸎󳦢󷟩󷿠󳯂󶩰󳯂󵷒󵹤󶊢󵬇󴍁󶩰󳯂󷋅󳗸

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󵰠󵥪󳤷󳯂󷋅󳘱󵼕󶅷󳔮󴛄󾘉CBER󾘊

󳡾󶩰󳔮󴛄󾘉CVM󾘊󵷒󶊢󳖌󳦢󳦟󳡭󴊥

󾘉ORA󾘊

2006 󴕵 9 󴸉 󶩰󳯂󵰠󳖨

󷐩󷣐󶊢󵬇󷃅󶨄󾘉CGMP󾘊

󶩰󳯂 CGMP 󵏖󷃅󵶅󷐩󷣐󳙔󶏼󴲺󵏖󶽍󳔛󴨈󳩘

󷾞󴀗󵶅󳥰󴸭󳫰󳗏󳗦󳔌󵔡󷝔󶪸󳫗󾘛

󳻺󷊮󳔏󵎠󷜛󳦟󳡭󴊥

󶩰󳯂󳛢󴝰󴀅󾘍HFD-240

󶩰󳯂󷋅󳗸󳮍󵼕󶅷󳔮󴛄

󷿠󳯂󶩰󳯂󵷒󵹤󶊢󵬇󴍁

󷐺󶤎󴌕󷓰 5600 󳫸

󸅭󷣍󳡱󴓟󶙘󳡌󶗵󴌕󴔃 20857 󳫸

󵰶󷋞󾘛301-827-4573

http://www.fda.gov/cder/guidance/index.htm

󴤗󶜆

󷜛󷊰󱜂󳻺󷊮󳔏󳦟󳡭󴊥

󵰠󵥪󳤷󳯂󷋅󳘱󵼕󶅷󳔮󴛄 HFM-40 󳤷󷜡󳱇󳩐󳦪󷟩

󷿠󳯂󶩰󳯂󵷒󵹤󶊢󵬇󴍁 1401 󶙘󳡌󶗵󴌕󴀨󷝔󾘍󶙘󳡌󶗵󴌕󾘍󸅭

󷣍󳡱󴓟 20852-1448 http://www.fda.gov/cber/guidelines.

htm.󾘉󵰶󷋞󾘊800-835-4709 󴤗 301-827-180

󴤗󶜆

HFV-12 󷜛󳛢󶗅

󳡾󶩰󳔮󴛄

󷿠󳯂󶩰󳯂󵷒󵹤󶊢󵬇󴍁

󸅭󷣍󳡱󴓟󶙘󳡌󶗵󴌕󴔃󴲰󳹧󷛫󳗁󴖀󳸻 7519 󳫸󾘍󷞯󶘗 2085

󵰶󷋞󾘛301-827-380

http://www.fda.gov/cvm/guidance/published.html

󶚏󳷾󳩬󵰠󳔏󳡭󳘘󴸎󳦢󷟩󷿠󳯂󶩰󳯂󵷒󵹤󶊢󵬇󴍁󶩰󳯂󷋅󳗸󳮍󵼕󶅷󳔮󴛄

󾘉CDER󾘊

󵰠󵥪󳤷󳯂󷋅󳘱󵼕󶅷󳔮󴛄󾘉CBER󾘊

󳡾󶩰󳔮󴛄󾘉CVM󾘊󵷒󶊢󳖌󳦢󳦟󳡭󴊥󾘉ORA󾘊

2006 󴕵 9 󴸉 󶩰󳯂󵰠󳖨󷐩󷣐󶊢󵬇󷃅󶨄󾘉CGMP󾘊

󴹢󳚌

Contains Nonbinding Recommendations

󵷯󴙖

󴤒. 󶊁󳗌 ....................................................................................................................................... 1

II. 󶟍󴵰󳔏󵷯󵶅............................................................................................................................ 1

A. 󶟍󴵰 .....................................................................................................................................................................1

B. 󴨈󳩘󵶅󵷯󴼈 .........................................................................................................................................................2

C. 󴨈󳩘󵶅󶨄󳷵 .........................................................................................................................................................3

D. 󴸭󴨈󳩘󵶅󶗅󶗈󴺷󴺅 .............................................................................................................................................4

III. CGMPS 󳔏󵪱󳗤󷐩󷣐󳙔󶏼󵂃󴛶 ........................................................................................... 4

A. ......................................................................................................................................................................4 󷐩󷣐

B. 󳻻󳖏󷊿󷊢󵶅󷐩󷣐󳔏󳖨󳯂󴘁󳫒 .............................................................................................................................4

C. 󷐩󷣐󷿏󷵪󶊢󵬇 .....................................................................................................................................................5

D. CAPA󾘉󶖡󵉤󳮍󷾅󷴳󴪫󴲾󾘊...............................................................................................................................5

E. 󳫙󴷵󴪨󳤷 .............................................................................................................................................................5

F. 󷐩󷣐󷟩󷳩 .............................................................................................................................................................5

G. 󳡮󶏼󶗠󴿁󴻦󵄢󳺌..................................................................................................................................................6

IV. 󷐩󷣐󳙔󶏼󵄢󳺌 ....................................................................................................................... 8

A. 󶊢󵬇󶝍󷐤 .............................................................................................................................................................8

1. 󴫑󳚜󷾇󴋽󳦜.........................................................................................................................................................8

2. 󶗅󶗈󴺷󴺅 ............................................................................................................................................................9

3. 󴺅󴗻󴞩󵶅󷐩󷣐󳙔󶏼󳗦󵗢󷒴󷂂󵍃 .......................................................................................................................9

4. 󳤷󴊛󴱀󶉗󱜂󵷯󴼈󳮍󷊢󳤓.....................................................................................................................................10

5. 󴊢󴻦󶏼󶗠 ...........................................................................................................................................................10

B. 󷑅󵖑 ...................................................................................................................................................................12

1. 󴜼󳙔󴔄󶙯 ...........................................................................................................................................................12

2. 󳖻󳭙󳫒󴍖 ...........................................................................................................................................................13

3. 󷊿󴲾󳔏󷊿󴀈........................................................................................................................................................13

4. 󴪨󳤷󴀗󳨆󳔛󳦢 ..................................................................................................................................................14

C. 󳤷󷜡 ..................................................................................................................................................................15

1. 󷊿󷊢󱜂󴘁󳫒󴕷󷊱󴙖󳖨󳯂󳫋󵑂󶄌 ..........................................................................................................................15

2. 󴊢󷃇󷚔󳡦 ..........................................................................................................................................................16

3. 󴥨󶽍󳮍󵷒󴪨󴯎󳙝 .............................................................................................................................................17

4. 󴀅󵬇󳔎󳬉󴼽󷽺...................................................................................................................................................19

D. 󷋅󳘱󵐼󳦩............................................................................................................................................................21

1. 󳤇󴺑󴱱󴩯󳗦󳫒󵪱󷒌󳧀 ......................................................................................................................................21

2. 󷛜󶽍󳢆󷟩󴊢󷊢....................................................................................................................................................21

3. 󷐩󷣐󷿏󷵪󶊢󵬇..................................................................................................................................................22

4. 󶖡󵉤󴪫󴲾............................................................................................................................................................22

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标签： #质量体系 #CGMP #GMP

摘要：

oTCGMPlvOSelLNcSWVSkuNQlOgRToTvwctoTNTxzvNCDERuriR6TO0xzvNCBERQoNCVMvNRRQlORA2006t9goTuNtCGMPoTCGMPlvOSelLNcSWYvRogSNNNnSSWNlRQloTOoYHFD240oTNTxzvNToTvwct95600SlQpWQK20857Su53018274573httpwwwfdagovcderguidanceindexhtmb0WNRQluriR6TO0xzvNHFM40R6UFSORToTvwct1401WQKYSWQKlQp208521448httpwwwfdagovcberguid...

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行业质量体系在药品CGMP法规方面的指导原则(中文)

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