美国FDA验证高级培训.pdf

美国FDA验证高级培训
Denis Kluba 博士
吴培栋博士
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目录Table Of Contents
1. 验证定义
2. CGMP对验证的要求
3. 验证历史与期望
4. 验证综述
5. 验证主方案与规划
6. 实施验证的方法
7. 验证的技术内容要求
8. 执行验证方案
9. 工作流程
10. 改变控制
11. 再验证
12. 总结
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Part One: What i s V alid at ion?
第第部分一部分:验证定义
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What is Validation?
验证的含义?
• For this Seminar it refers to two things:
• 1. The USA FDA requirements that must be met
in order to essfully and continually sell drug
products in the USA
• 2. Activities that will contribute to the ess of
pany in the manufacture of drug products
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Validation
业内对验证的理解
“Anything which you cannot understand is
indistinguishable from magic.”
• Arthur C. Clark
“Validation may not be magic! ”
• C. Edwards
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Validation Is.....
FDA对验证的定义
“Documented evidence which ppgrovides a high
degree of assurance that a specific process
will consistently produce a product meeting
ididifiidliits predetermined specifications and quality
attributes.”
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Why Do We Validate?
验证的作用/目的
To Consistently Produce
Product
Compliance A Desired Known
Product
Confirm
Design
Test within
Specifi cati on
Establish Operating
BdiBoundaries
Establish Baselines
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Details Will
How Do We Validate? Follow But This
is the General
验证流程图 Model
Identify Equipment Amend
Develop Tests
Systems Test
Conduct Tests Amend
Write Protocols Protocol
Collect Data
Evaluate Data Results OK? No
RtRltReport Results yes
Validated System
System Modified? 8
First three steppps to pliance
符合CGMP要求的头三步
• document
• document
• document
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Boundaries of Validation
验证的界限/范围
DOCUMENTED
COMMISSIONING PROGRAM STANDARD OPERATING
START-UP HIGH DEGREE OF PROCEDURES
ASSURANCE MFG BATCH RECORDS
TROUBLE SHOOTING CONSISTENTLY
PERSONNEL TRAINING
TRIAL RUNS MEETS
PREDETERMINED CALIBRATION
CYCLE DEVELOPMENT
SPECIFICATIONS PREVENTATIVE MTCE
PROCESS DEVELOPMENT CHANGE CONTROL
ENGINEERING PLIANCE
VENDOR AUDITS
VENDOR SERVICE REPORT