美国FDA验证高级培训资料ppt课件.ppt

美国FDA验证高级培训
Denis Kluba 博士
吴培栋博士
1
目录Table Of Contents
验证定义
CGMP对验证的要求
验证历史与期望
验证综述
验证主方案与规划
实施验证的方法
验证的技术内容要求
执行验证方案
工作流程
改变控制
再验证
总结
2
Part One: What is Validation?
?
第一部分:验证定义
3
What is Validation?
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
验证的含义?
4
Validation
“Anything which you cannot understand is indistinguishable from magic.”
Arthur C. Clark
“Validation may not be magic!”
C. Edwards
业内对验证的理解
5
How Do We Validate?
Details Will Follow But This is the General Model
Identify Equipment
Systems
Develop Tests
Write Protocols
Conduct Tests
Evaluate Data
Report Results
Results OK?
yes
No
Amend
Protocol
Amend
Test
Collect Data
Validated System
System Modified?
验证流程图
8
First three steps to pliance
document
document
document
符合CGMP要求的头三步
9
Boundaries of Validation
Engineering
COMMISSIONING
START-UP
TROUBLE SHOOTING
TRIAL RUNS
CYCLE DEVELOPMENT
PROCESS DEVELOPMENT
ENGINEERING STUDIES
VENDOR SERVICE REPORTS
FACTORY ACCEPTANCE TEST
“AS-BUILT” DRAWINGS
STANDARD OPERATING
PROCEDURES
MFG BATCH RECORDS
PERSONNEL TRAINING
CALIBRATION
PREVENTATIVE MTCE
CHANGE CONTROL
COMPLIANCE
VENDOR AUDITS
ANNUAL REVIEWS
COMPLAINTS
SAFETY
Operations / QA
Validation
DOCUMENTED
PROGRAM
HIGH DEGREE OF
ASSURANCE
CONSISTENTLY
MEETS
PREDETERMINEDSPECIFICATIONS
验证的界限/范围
10