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Cipla
Patalganga
Supersedes:
30.12.2004
VALIDATION MASTER PLAN
YEAR: 2006
Date of Issue:
Effective Date :
Page PAGE 30 of 26
TABLE OF CONTENTS
Sr.
CONTENT
Page No.
1.0
INTRODUCTION介绍:
3
2.0
OBJECTIVE 目的:
3
3.0
VALIDATION POLICY验证方针:
3
4.0
SCOPE 范围:
4
5.0
ORGANISATION AND RESPONSIBILITIES 职责:
8
5.1
Overall Validation Program Support systems 验证支持系统
8
5.1.1 Documentation control system 文件控制系统:
8
5.1.2 Protocol and documentation system验证方案系统:
8
5.1.3 Protocol execution system方案执行系统:
8
5.1.4 Change control system 变更控制系统:
8
5.2
Responsibilities 职责
9
5.2.1 Validation team members验证小组:
9
5.2.2 Production生产部:
9
5.2.3 Quality Control 质量控制部:
10
5.2.4 Engineering设备部:
10
5.2.5 Quality Assurance质量保证部:
11
6.0
VALIDATION DESCRIPTION
12
6.1
Facility Validation
12
6.1.1 Facility validation overview
12
6.1.2 Facility Description
12
6.2
Equipment Validation
12
6.2.1 Equipment Validation Overview
12
6.2.2 Equipment Description
13
6.3
Manufacturing Process / Cleaning Validation
13
6.3.1 Manufacturing Process / Cleaning validation Overview
13
6.3.2 Manufacturing process / cleaning validation description
13
6.4
Computer system Validation
14
6.4.1 Computer system Validation overview
14
6.4.2 Computer Hardware and Software qualification
14
Sr.
CONTENT
Page No.
6.5
Utilities Validation
16
6.5.1 Utilities Validation Overview
16
6.5.2 Utilities Validation Description
16
6.6
Analytical System Validation
18
Analytical System Validation overview
18
Analytical System Validation Description
18
Analytical System Validation documentation systems
18
Analytical System Validation Protocol format
18
Qualification of computer hardware and software used to control analytical equipment / systems
19
6.7
Personnel planning and schedules
19
6.8
Validation documentation organisation, summaries and reports
20
6.8.1 Process / Cleaning validation protocols / reports
20
6.8.2 Qualification protocol content and structure
21
6.8.2.1 User requirement specification (URS)
22
6.8.2.2 Functiona
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