FDA最新指导原则：药物分析程序及方法验证指导原则.pdf

Guidance for Industry Analytical Procedures and Methods Validation for Drugs and Biologics DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to . Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this draft document contact (CDER) Lucinda Buhse 314-539-2134, or (CBER) Office of Communication, Outreach and Development at 800-835-4709 or 301-827- 1800. 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) February 2014 CMC Guidance for Industry Analytical Procedures and Methods Validation for Drugs and Biologics Additional copies are available from: Office of Communications Division of Drug Information, WO51, Room 220 1 Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave