LEADER 03135nam 22006254a 450 001 9911020121703321 005 20200520144314.0 010 $a9786610448081 010 $a9781280448089 010 $a1280448083 010 $a9780470239384 010 $a0470239387 010 $a9780471784784 010 $a0471784788 010 $a9780471784777 010 $a047178477X 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(Perlego)2758778 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 $ea practical guide /$fDavid M. Bliesner 210 $aHoboken, N.J. $cWiley-Interscience$dc2006 215 $a1 online resource (295 p.) 300 $aDescription based upon print version of record. 311 08$a9780471738404 311 08$a0471738409 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$zUnited States 615 0$aPharmaceutical industry 615 0$aDrugs$xLaw and legislation 676 $a343.7307/86151 700 $aBliesner$b David M$0890967 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9911020121703321 996 $aEstablishing a CGMP laboratory audit system$94416910 997 $aUNINA