FDA工艺验证总则指南.docx

GUIDELINE ON GENERAL PRINCIPLES OF PROCESS VALIDATION 工艺验证总则指南 MAY, 1987 1987 年 5 月 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 起草：药物审评与争论中心，生物学评估与争论中心器械及放射学卫生中心 食品药品治理