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