FDA拌混粉和成品-分层取样和评价.pdfVIP

Guidance for Industry Powder Blends and Finished Dosage Units — Stratified In-Process Dosage Unit Sampling and Assessment DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 comments to Dockets Management Branch (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 Jon E. Clark, 301-594-5613 or Mike Gavini, 301-827-9053. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) October 2003 Pharmaceutical CGMPs G:\5831dft.doc 10/27/03 Guidance for Industry Powder Blends and Finished Dosage Units — Stratified In-Process Dosage Unit Sampling and Assessment Additional copies are available from: Office of Training and Communication Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 /cder/guidance/index.htm U.S. Department of Health and Human Services