LEADER 01888nam  2200469Ia 450 
001 9910698710903321
005 20090803150137.0
035   $a(CKB)5470000002396751
035   $a(OCoLC)319539400
035   $a(EXLCZ)995470000002396751
100   $a20090428d2008      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aGuidance for industry$b[electronic resource] $econtainer and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products
210  1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Veterinary Medicine,$d[2008]
215   $ai, 6 pages $cdigital, PDF file
300   $aTitle from PDF title page (viewed on Apr. 28, 2009).
300   $a"February 2008."
517   $aGuidance for industry 
606   $aContainers$xTesting
606   $aCaps and closures$zUnited States$xTesting
606   $aBiologicals$zUnited States
606   $aDrugs$zUnited States
606   $aMedical instruments and apparatus$zUnited States
615  0$aContainers$xTesting.
615  0$aCaps and closures$xTesting.
615  0$aBiologicals
615  0$aDrugs
615  0$aMedical instruments and apparatus
712 02$aCenter for Biologics Evaluation and Research (U.S.)
712 02$aCenter for Drug Evaluation and Research (U.S.)
712 02$aCenter for Devices and Radiological Health (U.S.)
712 02$aCenter for Veterinary Medicine (U.S.)
801  0$bGPO
801  1$bGPO
906   $aBOOK
912   $a9910698710903321
996   $aGuidance for industry$93434577
997   $aUNINA