FDA工艺验证指南.docVIP

GUIDELINE ON GENERAL PRINCIPLES OF PROCESS VALIDATION May, 1987 Prepared by: Center for Drugs an[下载自管理资源吧]d Biologics and Center for Devices and Radiological Health Food and Drug Administration Maintained by: Division of Manufacturing and Product Quality (HFN-320) Office of Compliance Center for Drugs and Biologics Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 General Principles of Process Validation May 1987