工艺验证通用原指南.docVIP

《美国FDA认证与申办指南》 权威资讯系列 《工艺验证的通用原则指南GUIDELINE ON GENERAL PRINCIPLES OF PROCESS VALIDATION 美国洲际药业有限公司 网址： 电子邮件：ellen@AllianceP GUIDELINE ON GENERAL PRINCIPLES OF PROCESS VALIDATION 工艺验证的通用原则指南 Prepared by: Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health Food and Drug Administration Maintained by: Division of Manufacturing and Product Quality (HFD-320) Office of Compliance Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 Reprinted