欧洲药品gmp检查指南

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1、PHARMACEUTICALINSPECTIONCONVENTIONPHARMACEUTICALINSPECTIONCO-OPERATIONSCHEMEPE009-21July2004肁羆薁蒂螁膁蒇薁袃羄莃薀羆膀艿薀蚅羃芅蕿袈芈薄薈羀肁蒀薇肂芆莆薆螂聿节薅袄芅膈蚄羇肇蒆蚄蚆芃莂蚃蝿肆莈蚂羁莁芄蚁肃膄薃蚀螃羇葿虿袅膂莅蚈羇羅芁螈蚇膁膇螇蝿羃蒅螆袂腿蒁螅肄羂莇螄螄芇芃螃袆肀薂螃羈芅蒈螂肁肈莄袁螀芄芀蒇袃肇膆蒆羅节薄蒆螅肅蒀蒅袇莀莆蒄罿膃节蒃肁羆薁蒂螁膁蒇薁袃羄莃薀羆膀艿薀蚅羃芅蕿袈芈薄薈羀肁蒀薇肂芆莆薆螂聿节薅袄芅膈蚄羇肇蒆蚄蚆芃莂蚃蝿肆莈蚂羁莁芄蚁肃膄薃蚀螃羇葿虿袅膂莅蚈

2、羇羅芁螈蚇膁膇螇蝿羃蒅螆袂腿蒁螅肄羂莇螄螄芇芃螃袆肀薂螃羈芅蒈螂肁肈莄袁螀芄芀蒇袃肇膆蒆羅节薄蒆螅肅蒀蒅袇莀莆蒄罿膃节蒃肁羆薁蒂螁膁蒇薁袃羄莃薀羆膀艿薀蚅羃芅蕿袈芈薄薈羀肁蒀薇肂芆莆薆螂聿节薅袄芅膈蚄羇肇蒆蚄蚆芃莂蚃蝿肆莈蚂羁莁芄蚁肃膄薃蚀螃羇葿虿袅膂莅蚈羇羅芁螈蚇膁膇螇蝿羃蒅螆袂腿蒁螅肄羂莇螄螄芇芃螃袆肀薂螃羈芅蒈螂肁肈莄袁螀芄芀蒇袃肇膆蒆羅节薄蒆螅肅蒀蒅袇莀莆蒄罿膃节蒃肁羆薁蒂螁膁蒇薁袃羄莃薀羆膀艿薀蚅羃芅蕿袈芈薄薈羀肁蒀薇肂芆莆薆螂聿节GUIDETOGOODMANUFACTURINGPRACTICEFORMEDICINALPRODUCTS药品GMP检查指南.PIC

3、/SJuly2004Reproductionprohibitedforcommercialpurposes.Reproductionforinternaluseisauthorised,providedthatthesourceisacknowledged.Editor:PIC/SSecretariatP.O.Box5695CH-1211Geneva11e-mail:daniel.brunner@picscheme.orgwebsite:http://www.picscheme.org1July2004PE009-2TableofcontentsTABLEOFCONTE

4、NT目录INTRODUCTION介绍1CHAPTER1QUALITYMANAGEMENT质量管理4PRINCIPLE原则4QUALITYASSURANCE质量保证4GOODMANUFACTURINGPRACTICEFORMEDICINALPRODUCTS(GMP)药品GMP6QUALITYCONTROL质量控制7CHAPTER2PERSONNEL人员10PRINCIPLE原则10GENERAL通则10KEYPERSONNEL关键人员10TRAINING培训13PERSONALHYGIENE个人卫生14CHAPTER3PREMISESANDEQUIPMENT厂房和设备16

5、PRINCIPLE原则16PREMISESGeneral总则16ProductionArea生产区域17StorageAreas储存区域19QualityControlAreas质量控制区域20AncillaryAreas辅助区域20EQUIPMENT设备21CHAPTER4DOCUMENTATION文件23PRINCIPLE原则23GENERAL总则23DOCUMENTSREQUIRED必需的文件25MANUFACTURINGFORMULAANDPROCESSINGINSTRUCTIONS生产方法和加工指示27PACKAGINGINSTRUCTIONS包装指示28BA

6、TCHPROCESSINGRECORDS批加工记录29BATCHPACKAGINGRECORDS批包装记录30PROCEDURESANDRECORDS程序和记录32CHAPTER5PRODUCTION生产36PRINCIPLE原则36GENERAL通则36PREVENTIONOFCROSS-CONTAMINATIONINPRODUCTION生产过程中防止交叉污染38VALIDATION验证39STARTINGMATERIALS起始物料40PROCESSINGOPERATIONS-INTERMEDIATEANDBULKPRODUCTS加工操作：中间体和散装产品42PACK

7、AGINGMATERIALS包装材料42PACKAGINGOPERATIONS包装操作43FINISHEDPRODUCTS最终成品45REJECTED,RECOVEREDANDRETURNEDMATERIALS拒绝的，回收的和退回的物料461July2004-v-PE009-2TableofcontentsCHAPTER6QUALITYCONTROL质量控制48PRINCIPLE原则48GENERAL通则48GOODQUALITYCONTROLLABORATORYPRACTICE优良质量控制实验室实践49DOCUMENTATION文件49