实验室控制GMP实施指南.docx

实验室控制GMP实施指南.docx

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实验室控制GMP实施指南

实验室控制系统GMP实施指南

1前言...............................................................................................................................................1

2目的...............................................................................................................................................2

3范围...............................................................................................................................................3

4指南内容结构...............................................................................................................................4

5.质量控制实验室总体描述............................................................................................................5

5.1职责....................................................................................................................................5

5.2布局....................................................................................................................................5

5.2.1原则..........................................................................................................................5

5.2.2要求.........................................................................................................................5

5.3人员....................................................................................................................................6

5.3.1组织架构.................................................................................................................6

5.3.2资质要求.................................................................................................................6

5.3.3培训.........................................................................................................................6

5.4文件系统....................................................................................................................................7

5.4.1分类.........................................................................................................................7

5.4.2要求.........................................................................................................................7

6取样.............................................................................................................................................10

6.1

6.2

6.3

6.4

定义.........................................................................................................................11

应用范围.................................................................................................................12

要求.........................................................................................................................12

6.3.1人员........................................................................................................................12

6.3.2取样器具................................................................................................................12

6.3.3样品容器................................................................................................................13

6.3.4取样间....................................................................................................................13

流程实施.................................................................................................................13

6.4.1取样方案................................................................................................................13

6.4.2取样........................................................................................................................14

6.4.3标识........................................................................................................................14

6.4.4取样记录................................................................................................................14

6.4.5取样的异常处理....................................................................................................14

6.4.6留样........................................................................................................................15

7试剂及试液的管理.....................................................................................................................17

7.1定义和应用范围..............................................................................................................17

7.2要求..................................................................................................................................17

7.2.1采购接收和标识...................................................................................................17

7.2.2储存和使用...........................................................................................................18

7.2.3试剂使用效期的管理...........................................................................................18

7.2.4报废.......................................................................................................................18

7.2.5文件管理...............................................................................................................18

8标准品/对照品............................................................................................................................19

8.1定义..................................................................................................................................19

8.2分类..................................................................................................................................19

8.3应用范围..........................................................................................................................20

8.4要求..................................................................................................................................20

8.4.1接收.......................................................................................................................20

8.4.2标识.......................................................................................................................20

8.4.3标准溶液的稳定性研究.......................................................................................20

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实验室控制系统GMP实施指南

8.4.4标准品、对照品的使用、处置和贮存...............................................................21

8.4.5文件管理...............................................................................................................21

9实验室分析仪器的确认.............................................................................................................22

9.1应用范围..........................................................................................................................23

9.2确认实施..........................................................................................................................24

9.2.1验证总计划...........................................................................................................24

9.2.2确认方案...............................................................................................................24

9.2.3确认实施...............................................................................................................25

9.2.4确认报告...............................................................................................................27

9.2.5系统适用性试验...................................................................................................27

9.2.6实验室仪器控制系统和数据处理系统的确认...................................................27

9.2.7再确认...................................................................................................................28

10实验室分析仪器的校准与维护...............................................................................................32

10.1定义................................................................................................................................33

10.2应用范围........................................................................................................................33

10.3要求................................................................................................................................33

10.3.1人员.....................................................................................................................33

10.3.2分类.....................................................................................................................34

10.3.3实施指导.............................................................................................................34

10.3.4文件.....................................................................................................................36

11分析方法的验证和确认...........................................................................................................45

11.1分析方法........................................................................................................................46

11.2方法验证........................................................................................................................46

11.3方法确认........................................................................................................................47

11.4适用范围........................................................................................................................47

11.5方法验证的一般原则....................................................................................................47

11.6需要验证的检验项目....................................................................................................47

11.7方法验证内容................................................................................................................49

11.7.1准确度....