Guidance for industry : container and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products.

Bibliographic Details
Corporate Authors:	Center for Biologics Evaluation and Research (U.S.), Center for Drug Evaluation and Research (U.S.), Center for Devices and Radiological Health (U.S.), Center for Veterinary Medicine (U.S.)
Format:	Government Document eBook
Language:	English
Published:	Rockville, MD : U.S. Dept. 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, [2008]
Subjects:	Containers > Testing. Caps and closures > United States > Testing. Biologicals > United States. Drugs > United States. Medical instruments and apparatus > United States.
Online Access:	https://purl.fdlp.gov/GPO/LPS111964

Description
Item Description:	"February 2008". Title from PDF title page (viewed on Apr. 28, 2009). "February 2008." Electronic resource.
Physical Description:	i, 6 pages : digital, PDF file.
Format:	Mode of access: Internet at the FDA CBER Web site. Address as of 4/28/09: http://www.fda.gov/cber/gdlns/contain.pdf ; current access is available via PURL.