Guidance for Industry Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
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作者:pmo90dc87
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发布时间 :2018-08-16
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For questions on the content of the guidance, contact CBER’s Office of Compliance and Biologics Quality at 301-827-3031; CDER’s Office of Pharmaceutical Science at 301-796-1228; CDRH’s Office of Device Evaluation at 240-276-3747; or CVM’s Office of New Animal Drug Evaluation at 301-827-6963.
U. S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Center for Devices and Radiological Health Center for Veterinary Medicine February 2008
Guidance for Industry
Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
Additional copies of this guidance are available from:
Office of Communication, Training and Manufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448 Internet: http://www.fda.gov/cber/guidelines.htm Phone: 800-835-4709 or 301-827-1800 or 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 Phone: 301-827-4573 Internet: http://www.fda.gov/cder/guidance/index.htm or Division of Small Manufacturers, International, and Consumer Assistance (DSMICA), HFZ-220 Center for Devices and Radiological Health Food and Drug Administration 1350 Piccard Drive, Rockville, MD 20850 Phone: 800-638-2041 Internet: http://www.fda.gov/cdrh/guidance.html Email: dsmica@cdrh.fda.gov Fax: 240-276-3151 or Communications Staff, HFV-12 Center for Veterinary Medicine (CVM) Food and Drug Administration 7519 Standish Place Rockville, MD 20855 Internet at http://www.fda.gov/cvm/guidance/published.htm
