LEADER 01214nas 2200409- 450 001 9910148960603321 005 20200911053753.6 035 $a(OCoLC)964852644 035 $a(CKB)3710000000926624 035 $a(CONSER)--2017252576 035 $a(EXLCZ)993710000000926624 100 $a20161110a20129999 --- - 101 0 $aind 135 $aur|n||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aE-jurnal akuntansi 210 1$aDenpasar, Bali, Indonesia :$cJurusan Akuntansi, Fakultas Ekonomi dan Bisnis, Universitas Udayana, Bali,$d[2012]- 215 $a1 online resource 300 $aRefereed/Peer-reviewed 311 $a2302-8556 517 1 $aE-fournal of accounting 517 3 $aEJA 606 $aAccounting$vPeriodicals 606 $aAccounting$2fast$3(OCoLC)fst00795379 608 $aElectronic journals. 608 $aPeriodicals.$2fast 608 $aPeriodicals.$2lcgft 610 $aAccounting 615 0$aAccounting 615 7$aAccounting. 712 02$aUniversitas Udayana.$bJurusan Akuntansi, 906 $aJOURNAL 912 $a9910148960603321 996 $aE-jurnal akuntansi$92575799 997 $aUNINA LEADER 03068nam 22005774a 450 001 9910830871703321 005 20230828201103.0 010 $a1-280-44808-3 010 $a9786610448081 010 $a0-470-23938-7 010 $a0-471-78478-8 010 $a0-471-78477-X 035 $a(CKB)1000000000355049 035 $a(EBL)257215 035 $a(OCoLC)162401253 035 $a(SSID)ssj0000149621 035 $a(PQKBManifestationID)11150502 035 $a(PQKBTitleCode)TC0000149621 035 $a(PQKBWorkID)10239121 035 $a(PQKB)10043307 035 $a(MiAaPQ)EBC257215 035 $a(EXLCZ)991000000000355049 100 $a20050819d2006 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aEstablishing a CGMP laboratory audit system$b[electronic resource] $ea practical guide /$fDavid M. Bliesner 210 $aHoboken, N.J. $cWiley-Interscience$dc2006 215 $a1 online resource (295 p.) 300 $aDescription based upon print version of record. 311 $a0-471-73840-9 320 $aIncludes bibliographical references and index. 327 $aPreface -- Introduction to the quality systems approach to CGMP compliance -- Preparing for the audit -- Auditing and data capture -- Organizing data and reporting the results -- Developing and implementing a corrective action plan -- Developing and implementing a verification plan -- Developing and implementing a monitoring plan -- A summary for establishing a CGMP laboratory audit system -- Appendixes -- Example audit checklists: laboratory subelements -- Example template for an audit summary report -- Glossary of CGMP and audit system terms -- FDA compliance program guidance manual 7356.002 "Drug manufacturing inspections" -- 21 Code of U.S Federal Regulations parts 210 and 211 current good manufacturing practice regulations. 330 $aThe first systematic, hands-on auditing guide for today's pharmaceutical laboratoriesIn today's litigious environment, pharmaceutical laboratories are subject to ever stricter operational guidelines as mandated by the FDA, and must be able to establish and demonstrate sustainable operational practices that ensure compliance with the current good manufacturing practice (CGMP) regulations. David Bliesner's Establishing a CGMP Laboratory Audit System: A Practical Guide is designed to provide laboratory supervisors and personnel with a step-by-step, hands-on audit system that they can rely 606 $aPharmaceutical industry$zUnited States 606 $aDrugs$xLaw and legislation$zUnited States 610 $aCurrent Good Manufacturing Practices 615 0$aPharmaceutical industry 615 0$aDrugs$xLaw and legislation 676 $a343.7307/86151 676 $a542.1 700 $aBliesner$b David M$0890967 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910830871703321 996 $aEstablishing a CGMP laboratory audit system$94063827 997 $aUNINA