LEADER 01762nam 2200445Ia 450 001 9910699126003321 005 20230902162127.0 035 $a(CKB)5470000002400638 035 $a(OCoLC)464670680 035 $a(EXLCZ)995470000002400638 100 $a20091110d2004 ua 0 101 0 $aeng 135 $auran||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aGuidance for industry$b[electronic resource] $ePAT, a framework for innovative pharmaceutical development, manufacturing, and quality assurance 210 1$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 (16 pages) 300 $a"Center for Veterinary Medicine (CVM)." 300 $a"Office of Regulatory Affairs (ORA)." 300 $a"Pharmaceutical CGMPs." 300 $a"September 2004." 320 $aIncludes bibliographical references (page 16). 517 $aGuidance for industry 606 $aDrug development$xGovernment policy$zUnited States 606 $aDrug factories$xGovernment policy$zUnited States 606 $aQuality assurance$xGovernment policy$zUnited States 615 0$aDrug development$xGovernment policy 615 0$aDrug factories$xGovernment policy 615 0$aQuality assurance$xGovernment policy 712 02$aCenter for Drug Evaluation and Research (U.S.) 712 02$aCenter for Veterinary Medicine (U.S.) 712 02$aUnited States.$bFood and Drug Administration.$bOffice of Regulatory Affairs. 801 0$bGPO 801 1$bGPO 906 $aBOOK 912 $a9910699126003321 996 $aGuidance for industry$93434577 997 $aUNINA