Transcription of ( 配付用）高生理活性設備Part 1 - ph-s.com
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( 配付用）高生理活性設備Part 1 - ph-s.com
#Pharma Solutions Co., Ltd. 2009 03 GMP GMP EMEA Conceptual Paper ICH Q9 Step Risk=Severity Probability EFPIA Resource Paper ispe White Paper Risk=Hazard Exposure RISK MAPP Steering Committee #PenicillinCephalos-porinsCarbaPenemsCar baCephemOther -LactamsCurrent GMP1. FDA/CGMP 2. EU-GMP 3. J-GMP 4. WHO-GMP 5. PIC/S GMP Guidelines6. FDA Proposed CGMP Changes (1996) 7. ICH API GMP Guide (ICHQ7) : Segregated Facility : Campaign with necessary validation can be accepted FDA CDER (Safety Officer) 2008 ispe Washington Conference #GMP/ GuidanceLive microorganismsCertainHormones(Certain Steroids)CytotoxicsubstancesHig
FDA CDER (Safety Officer)の発表資料より 2008年ISPE Washington Conference 1．現行各極GMP・設備・施設の専用化の要件
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