Guidance for industry : container and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products.
| 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: | |
| Online Access: | https://purl.fdlp.gov/GPO/LPS111964 |
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