LEADER 03102nam  22005894a 450 
001 9910143411103321
005 20170815114451.0
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
608   $aElectronic books.
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   $a9910143411103321
996   $aEstablishing a CGMP laboratory audit system$91990201
997   $aUNINA