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Record Nr. |
UNINA9910143411103321 |
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Autore |
Bliesner David M |
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Titolo |
Establishing a CGMP laboratory audit system [[electronic resource] ] : 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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1-280-44808-3 |
9786610448081 |
0-470-23938-7 |
0-471-78478-8 |
0-471-78477-X |
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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 |
Electronic books. |
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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 |
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