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

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