Transcription of 5.2 생산공정과 밸리데이션 - contents.kocw.net
1 2003 KFDA (facility), (system), (equipment) (process) , (validation) : , , 1970 FDA 1970 LVP (large volume parental preparation) 1987 WHO, FDA, EU, ASEAN GMP 2004 , 100% . ) 10,000 20 98% . 4M 4M (protocol) (testing) (documentation) Protocol: / , , , GMP (Standard Operating Procedure.
2 SOP) : , , , , : , , , , , (equipment validation) (process validation) 1) (equipment validation) (installation qualification: IQ) , (operational qualification: OQ) 2) (process validation) * URS: user requirements specification (DQ) * F&DS: (design qualification report) (design risk analysis) , GMP 4M (manufacturing, Men, Method, Materials) + 1E (Environment) + Finished Product , (IQ) GMP , (IQ & OQ plan) (IQ protocol) (OQ protocol) (IQ report) (OQ report) (PQ) (Process validation) PV (Process Optimization) PAT(Process Analytical Technology.
3 (QC) Validation + QC Validation + PAT + (QC) PAT: PAT PAT PAT (QC) ( ).. PAT , PAT
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