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001 9910699115303321
005 20230902162029.0
035   $a(CKB)5470000002400747
035   $a(OCoLC)466422255
035   $a(EXLCZ)995470000002400747
100   $a20091117d2004      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aGuidance for industry$b[electronic resource] $esterile drug products produced by aseptic processing, current good manufacturing practice
210  1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,$d[2004]
215   $a1 online resource (59 pages)
300   $a"Center for Biologics Evaluation and Research (CBER)."
300   $a"Office of Regulatory Affairs (ORA)."
300   $a"Pharmaceutical CGMPs."
300   $a"September 2004."
320   $aIncludes bibliographical references (pages 54-55).
517   $aGuidance for industry 
606   $aDrugs$xSterilization$zUnited States
606   $aAsepsis and antisepsis
615  0$aDrugs$xSterilization
615  0$aAsepsis and antisepsis.
712 02$aCenter for Drug Evaluation and Research (U.S.)
712 02$aCenter for Biologics Evaluation and Research (U.S.)
712 02$aUnited States.$bFood and Drug Administration.$bOffice of Regulatory Affairs.
801  0$bGPO
801  1$bGPO
906   $aBOOK
912   $a9910699115303321
996   $aGuidance for industry$93434577
997   $aUNINA