2006/6/18

A Comparison of EU and US GMPs. 歐美GMP的比較

 
“FDA inspectors inspect for compliance; EU inspectors inspect for adequate science”. 
 
歐洲強調的重點: 
ØThe expectations of Quality Management and the role of the QP
ØThe expectation for, and extensiveness of, validation
ØThe need for self-inspection (=internal audits)
ØTraining and assessment of competence
ØThe role of contract manufacture and analysis

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