LEADER 01676nam  2200433Ia 450 
001 9910698126603321
005 20090324140449.0
035   $a(CKB)5470000002395717
035   $a(OCoLC)316871659
035   $a(EXLCZ)995470000002395717
100   $a20090324d2008      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aGuidance for industry$b[electronic resource] $eprocess validation, general principles and practices
210  1$aSilver Spring, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ;$aRockville, MD :$cCenter for Biologics Evaluation and Research (CBER) :$cCenter for Veterinary Medicine (CGMP),$d[2008]
215   $a20 unnumbered pages $cdigital, PDF file
300   $aTitle from PDF title page (viewed on Mar. 24, 2009).
300   $a"Draft guidance."
300   $a"November 2008."
320   $aIncludes bibliographical references (page [20]).
517   $aGuidance for industry 
606   $aBiologicals$xEvaluation
606   $aDrugs$xTesting
606   $aManufacturing processes$xEvaluation
615  0$aBiologicals$xEvaluation.
615  0$aDrugs$xTesting.
615  0$aManufacturing processes$xEvaluation.
712 02$aCenter for Drug Evaluation and Research (U.S.)
712 02$aCenter for Biologics Evaluation and Research (U.S.)
712 02$aCenter for Veterinary Medicine (U.S.)
801  0$bGPO
801  1$bGPO
906   $aBOOK
912   $a9910698126603321
996   $aGuidance for industry$93434577
997   $aUNINA