FDA工业指南--CGMP质量体系(中文译稿).pdfVIP

Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations 业界指南 ——制药企业 CGMP 规范的质量体系 U.S. 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) Office of Regulatory Affairs (ORA) September 2006 Pharmaceutical CG