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1. |
Record Nr. |
UNISALENTO991000395699707536 |
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Autore |
Trizzino, Antonino |
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Titolo |
Traditori in divisa |
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Pubbl/distr/stampa |
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Descrizione fisica |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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2. |
Record Nr. |
UNINA9911020121703321 |
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Autore |
Bliesner David M |
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Titolo |
Establishing a CGMP laboratory audit system : a practical guide / / David M. Bliesner |
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Pubbl/distr/stampa |
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Hoboken, N.J., : Wiley-Interscience, c2006 |
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ISBN |
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9786610448081 |
9781280448089 |
1280448083 |
9780470239384 |
0470239387 |
9780471784784 |
0471784788 |
9780471784777 |
047178477X |
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Descrizione fisica |
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1 online resource (295 p.) |
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Disciplina |
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Soggetti |
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Pharmaceutical industry - United States |
Drugs - Law and legislation - United States |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Description based upon print version of record. |
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Nota di bibliografia |
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Includes bibliographical references and index. |
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Nota di contenuto |
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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. |
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Sommario/riassunto |
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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 rely |
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