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COMPUTER FILE
Title Guidance for industry : 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]

LOCATION CALL # STATUS MESSAGE
 ONLINE GOVERNMENT PUBLICATION  HE 20.4802:C 76    ONLINE  
LOCATION CALL # STATUS MESSAGE
 ONLINE GOVERNMENT PUBLICATION  HE 20.4802:C 76    ONLINE  
Subject Containers -- Testing.
Caps and closures -- United States -- Testing.
Biologicals -- United States.
Drugs -- United States.
Medical instruments and apparatus -- United States.
Alt Name 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.)
Add Title Container and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products
Description i, 26 pages : digital, PDF file
monochrome rdacc
System Details 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.
Note Title from PDF title page (viewed on Apr. 28, 2009).
"February 2008".
OCLC # 319539400


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