FDA-无菌药品生产指南(中英文版)介绍

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Translated from / 译自：

Guidance for Industry

Sterile Drug Products

Produced by Aseptic Processing —

Current Good Manufacturing Practice

行业指南

无菌加工生产的无菌药品

—现行的生产质量管理规范(cGMP）

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

Center for Biologics Evaluation and Research (CBER)

Office of Regulatory Affairs (ORA)

September 2004

Pharmaceutical CGMPs

Guidance for Industry

Sterile Drug Products

Produced by Aseptic Processing —

Current Good Manufacturing Practice

Additional copies are available from:

Office of Training and Communication

Division of Drug Information, HFD-240

Center for Drug Evaluation and Research

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857

(Tel) 301-827-4573

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

Office of Communication, Training and

Manufacturers Assistance, HFM-40

Center for Biologics Evaluation and Research

Food and Drug Administration

1401 Rockville Pike, Rockville, MD 20852-1448

http://www.fda.gov/cber/guidelines.htm.

(Tel) Voice Information System at 800-835-4709 or 301-827-1800

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

Center for Biologics Evaluation and Research (CBER)

Office of Regulatory affairs (ORA)

September 2004

Pharmaceutical CGMPs

Contains Nonbinding Recommendations

TABLE OF CONTENTS

I. INTRODUCTION............................................................................................................. 1

简介

II. BACKGROUND ............................................................................................................... 2

背景

A. Regulatory Framework ................................................................................................................. 2

法规架构

B. Technical Framework .................................................................................................................... 3

技术架构

III. SCOPE ............................................................................................................................... 4

适用范围

IV. BUILDINGS AND FACILITIES .................................................................................... 6

厂房和建筑

A. Critical Area – Class 100 (ISO 5) ................................................................................................. 8

关键区域– 100 级 (ISO 5)

B. Supporting Clean Areas .............................................................................................................. 11

辅助洁净区域

C. Clean Area Separation ................................................................................................................ 11

净化区的隔离

D. Air Filtration ................................................................................................................................ 12

空气过滤

1. Membrane ...................................................................................................................................... 13

膜过滤

2. High-Efficiency Particulate Air (HEPA) ....................................................................................... 14

高效颗粒空气过滤器

(HEPA)

E. Design ............................................................................................................................................ 16

设计

V. PERSONNEL TRAINING, QUALIFICATION, & MONITORING ........................ 20

人员的培训，资格认定和监控

A. Personnel ....................................................................................................................................... 21

人员

B. Laboratory Personnel .................................................................................................................. 25

实验室人员

C. Monitoring Program .................................................................................................................... 25

监控程序

VI. COMPONENTS AND CONTAINER/CLOSURES .................................................... 27

药品成分和容器/密封

A. Components .................................................................................................................................. 27

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标签： #指南 #无菌 #FDA

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CopyrightSCIVersion1Translatedfrom/译自：GuidanceforIndustrySterileDrugProductsProducedbyAsepticProcessing—CurrentGoodManufacturingPractice行业指南无菌加工生产的无菌药品—现行的生产质量管理规范(cGMP）U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluation...

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