歐盟gmp中英文對(duì)照_第1頁(yè)
已閱讀1頁(yè)，還剩66頁(yè)未讀， 繼續(xù)免費(fèi)閱讀

下載本文檔

版權(quán)說(shuō)明：本文檔由用戶提供并上傳，收益歸屬內(nèi)容提供方，若內(nèi)容存在侵權(quán)，請(qǐng)進(jìn)行舉報(bào)或認(rèn)領(lǐng)

文檔簡(jiǎn)介

1、EuropeanUnion藥品生品生產(chǎn)質(zhì)產(chǎn)質(zhì)量管理量管理規(guī)范GUIDETOGOODMANUFACTURINGPRACTICEFMEDICINALPRODUCTSTherulesgoverningmedicinalproductsintheEuropeanUnion藥品生產(chǎn)質(zhì)量管理規(guī)范藥品生產(chǎn)質(zhì)量管理規(guī)范2質(zhì)量控制區(qū)..............................................................

2、.........................................................22QualityControlArea.............................................................................................................22附助區(qū).............................

3、....................................................................................................22AncillaryAreas........................................................................................................

4、..............22設(shè)備......................................................................................................................................23Equipment.........................................................

5、.....................................................................23第四章第四章文件文件CHAPTER4:DOCUMENTATION.....................................................................................24原則............................

6、..........................................................................................................24Principle.......................................................................................................

7、..........................24通則......................................................................................................................................25General...............................................

8、....................................................................................25文件要求.............................................................................................................................27Doc

9、umentsRequired..............................................................................................................27Specifications................................................................................

10、..........................................27Specificationsfstartingpackagingmaterials...............................................................27SpecificationsfIntermediateBulkProducts...............................

11、.................................27SpecificationsfFinishedProducts......................................................................................28ManufacturingFmulaeProcessingInstructions.........................

12、..................................28PackagingInstructions............................................................................................................30BatchProcessingRecds.................................

13、......................................................................31BatchPackagingRecds.......................................................................................................32ProceduresRecds.........

14、................................................................................................33Receipt...................................................................................................................

15、..................34Sampling..................................................................................................................................34Testing.....................................................

16、................................................................................35Other.....................................................................................................................................

17、...35第五章第五章生產(chǎn)CHAPTER5:PRODUCTION..............................................................................................36原則..........................................................................................

18、............................................36Principle...................................................................................................................................36通則..............................

19、........................................................................................................36General...........................................................................................................

20、..........................36生產(chǎn)過(guò)程中對(duì)交叉污染的預(yù)防....................................................................................39PreventionofCrosscontaminationinProduction...................................................

溫馨提示

  • 1. 本站所有資源如無(wú)特殊說(shuō)明，都需要本地電腦安裝OFFICE2007和PDF閱讀器。圖紙軟件為CAD,CAXA,PROE,UG,SolidWorks等.壓縮文件請(qǐng)下載最新的WinRAR軟件解壓。
  • 2. 本站的文檔不包含任何第三方提供的附件圖紙等，如果需要附件，請(qǐng)聯(lián)系上傳者。文件的所有權(quán)益歸上傳用戶所有。
  • 3. 本站RAR壓縮包中若帶圖紙，網(wǎng)頁(yè)內(nèi)容里面會(huì)有圖紙預(yù)覽，若沒(méi)有圖紙預(yù)覽就沒(méi)有圖紙。
  • 4. 未經(jīng)權(quán)益所有人同意不得將文件中的內(nèi)容挪作商業(yè)或盈利用途。
  • 5. 眾賞文庫(kù)僅提供信息存儲(chǔ)空間，僅對(duì)用戶上傳內(nèi)容的表現(xiàn)方式做保護(hù)處理，對(duì)用戶上傳分享的文檔內(nèi)容本身不做任何修改或編輯，并不能對(duì)任何下載內(nèi)容負(fù)責(zé)。
  • 6. 下載文件中如有侵權(quán)或不適當(dāng)內(nèi)容，請(qǐng)與我們聯(lián)系，我們立即糾正。
  • 7. 本站不保證下載資源的準(zhǔn)確性、安全性和完整性, 同時(shí)也不承擔(dān)用戶因使用這些下載資源對(duì)自己和他人造成任何形式的傷害或損失。

評(píng)論

0/150

提交評(píng)論