Transcription of (Guidance for Industry: Process Validation: General ...
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guidance for Industry: Process validation : General Principles and Practices GU053A gggmmmpppeeeyyyeee 1 : ( guidance for Industry: Process validation : General Principles and Practices) Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Veterinary Medicine (CVM) January 2011 Current Good Manufacturing Practices (CGMP) Revision 1 guidance for Industry: Process validation : General Principles and Practices GU053A gggmmmpppeeeyyyeee 2 : ( guidance for Industry: Process validation : General Principles and Practices) Additional copies are available from: Office of Communications Division of Drug Information, WO51, Room 2201 10903 New Hampshire Ave.
Guidance for Industry: Process Validation: General Principles and Practices GU053A ggmmppeeyyee www.gmpeye.co.kr 3 [목차] I. 서론(INTRODUCTION) II. 배경(BACKGROUND)
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