03068nam 22005774a 450 991083087170332120230828201103.01-280-44808-397866104480810-470-23938-70-471-78478-80-471-78477-X(CKB)1000000000355049(EBL)257215(OCoLC)162401253(SSID)ssj0000149621(PQKBManifestationID)11150502(PQKBTitleCode)TC0000149621(PQKBWorkID)10239121(PQKB)10043307(MiAaPQ)EBC257215(EXLCZ)99100000000035504920050819d2006 uy 0engur|n|---|||||txtccrEstablishing a CGMP laboratory audit system[electronic resource] a practical guide /David M. BliesnerHoboken, N.J. Wiley-Intersciencec20061 online resource (295 p.)Description based upon print version of record.0-471-73840-9 Includes bibliographical references and index.Preface -- 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.The 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 relyPharmaceutical industryUnited StatesDrugsLaw and legislationUnited StatesCurrent Good Manufacturing PracticesPharmaceutical industryDrugsLaw and legislation343.7307/86151542.1Bliesner David M890967MiAaPQMiAaPQMiAaPQBOOK9910830871703321Establishing a CGMP laboratory audit system4063827UNINA