EMA GMP 附录1 无菌产品生产(2022版）（中英文）

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EUROPEAN COMMISSION

欧盟委员会

Brussels,22.8.2022

2022年8月22日，布鲁塞尔

C(2022)5938 final

C(2022)5938 决赛

GUIDELINES

准则

The Rules Governing Medicinal Products in the European Union

欧盟药品管理规则

Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal

Products for Human and Veterinary Use

第4卷欧盟人用和兽用医药产品良好生产规范指南

Annex 1

附件一

Manufacture of Sterile Medicinal Products

无菌药品生产

1.0 Scope.......................................................................................................................................................................................7

范围...................................................................................................................................................................................... 7

2.0 Principle...............................................................................................................................................................................7

原则..................................................................................................................................................................................... 7

3.0 PharmaceuticalQualitySystem(PQS) .............................................................................................................................. 10

药品质量体系(PQS) ................................................................................................................................................... 10

4.0 Premises............................................................................................................................................................................. 11

厂房...................................................................................................................................................................................11

Barrier Technologies......................................................................................................................................................... 15

屏障技术 .......................................................................................................................................................................... 15

Cleanroom and clean air equipment qualification ....................................................................................................... 17

洁净室和洁净空气设备的确认 .....................................................................................................................................17

Disinfection ....................................................................................................................................................................... 21

消毒 ................................................................................................................................................................................... 21

5.0 Equipment.......................................................................................................................................................................... 2

设备 ...................................................................................................................................................................................2

6.0 Utilitie ...............................................................................................................................................................................23

公用设施 .......................................................................................................................................................................... 23

Water systems .................................................................................................................................................................. 24

水系统 ...............................................................................................................................................................................24

Steam used as a direct sterilising agent ..........................................................................................................................25

直接灭菌用蒸汽 ............................................................................................................................................................. 25

Gases and vacuum systems .............................................................................................................................................26

气体和真空系统 ........................................................................................................................................................... 26

Heating and cooling and hydraulic systems................................................................................................................... 26

加热、冷却和液压系统 ................................................................................................................................................. 26

7.0 Personnel .............................................................................................................................................................................

人员...................................................................................................................................................................................26

8.0 Production and Specific Technologies..................................................................................................................................

生产和具体技术............................................................................................................................................................. 30

Terminally sterilised products ....................................................................................................................................... 30

最终灭菌产品...................................................................................................................................................................30

Aseptic preparation and processing .................................................................................................................................. 31

无菌准备和工艺...............................................................................................................................................................31

Finishing of sterile products ........................................................................................................................................... 34

无菌产品的最终处理 ..................................................................................................................................................... 34

Sterilisation ....................................................................................................................................................................... 36

灭菌................................................................................................................................................................................... 36

Sterilisation by heat ......................................................................................................................................................... 39

加热灭菌...........................................................................................................................................................................39

Moist heat sterilisation ..................................................................................................................................................40

湿热灭菌........................................................................................................................................................................... 40

Dry heat sterilisation ....................................................................................................................................................... 41

干热灭菌........................................................................................................................................................................... 41

Sterilisation by radiation............................................................................................................................................... 43

辐射灭菌........................................................................................................................................................................... 43

Sterilisation with ethylene oxide ............................................................................................................................... 43

环氧乙烷灭菌.................................................................................................................................................................. 43

Filter sterilisation of products which cannot be sterilised in theirfinal container ...........................................44

不能在最终容器中灭菌的产品的过滤除菌 ............................................................................................................... 4

Form -Fill -Seal (FFS) .....................................................................................................................................................48

成型-灌装-密封(FFS) ................................................................................................................................................. 48

Blow-Fill -Seal...................................................................................................................................................................50

吹灌封 ............................................................................................................................................................................... 50

Lyophilization................................................................................................................................................................... 53

冻干 ................................................................................................................................................................................... 53

Closed systems............................................................................................................................................................... 55

密闭系统 ........................................................................................................................................................................... 55

Single use systems (SUS) .......................................................................................................................................... 55

一次性系统(SUS) ....................................................................................................................................................... 55

9.0 Environmental & process monitoring............................................................................................................................... 57

环境监测和工艺监测...................................................................................................................................................... 57

General .............................................................................................................................................................................57

总则 ................................................................................................................................................................................... 57

Environmental and process monitoring ................................................................................................................... 58

环境监测和工艺监测...................................................................................................................................................... 58

Environmental monitoring - total particle ............................................................................................................... 59

环境监测 -总微粒 .......................................................................................................................................................... 60

Environmental and personnel monitoring- viable particle .......................................................................................... 61

环境和人员监测 -活性微粒 .......................................................................................................................................... 61

Aseptic process simulation(APS)( alsoknown as mediafill) ......................................................................................63

无菌工艺模拟 ( APS )( 又称培养基模拟灌装 ) ..................................................................................................... 63

10.0 QualityControl(QC) ....................................................................................................................................................... 69

质量控制(QC) .............................................................................................................................................................. 69

11.0 Glossary ........................................................................................................................................................................... 71

术语表 ............................................................................................................................................................................... 71

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标签： #GMP #无菌 #附录

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1EUROPEANCOMMISSION欧盟委员会Brussels,22.8.20222022年8月22日，布鲁塞尔C(2022)5938finalC(2022)5938决赛GUIDELINES准则TheRulesGoverningMedicinalProductsintheEuropeanUnion欧盟药品管理规则Volume4EUGuidelinesforGoodManufacturingPracticeforMedicinalProductsforHumanandVeterinaryUse第4卷欧盟人用和兽用医药产品良好生产规范指南Annex1附件一ManufactureofSterile...

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