FDA行业指南：注射产品可见颗粒的检查-202112草案（中英文对照版）.pdf

FDA 行业指南：注射产品中可见颗粒的检查-2021 草案 Inspection of Injectable Products for Visible Particulates 注射产品中可见颗粒的检查 Guidance for Industry 行业指南 DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 Dockets Management Staff (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) Eric Dong 240-402-4172; (CBER) Office of Communication, Outreach and Development, 800-835-4709 or 240-402-8010; or (CVM) AskCVM@. 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) December 2021 Pharmaceutical Quality/CMC 1 / 25 FDA 行业指南：注射产品中可见颗粒的检查-2021 草案 Inspection of Injectable Products for Visible Particulates Guidance for Industry 注射产品中可见颗粒的检查 行业指南 Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug th Administration 10