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Establishing a CGMP laboratory audit system [[electronic resource] ] : a practical guide / / David M. Bliesner
| Establishing a CGMP laboratory audit system [[electronic resource] ] : a practical guide / / David M. Bliesner |
| Autore | Bliesner David M |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley-Interscience, c2006 |
| Descrizione fisica | 1 online resource (295 p.) |
| Disciplina |
343.7307/86151
542.1 |
| Soggetto topico |
Pharmaceutical industry - United States
Drugs - Law and legislation - United States |
| Soggetto genere / forma | Electronic books. |
| Soggetto non controllato | Current Good Manufacturing Practices |
| ISBN |
1-280-44808-3
9786610448081 0-470-23938-7 0-471-78478-8 0-471-78477-X |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 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. |
| Record Nr. | UNINA-9910143411103321 |
Bliesner David M
|
||
| Hoboken, N.J., : Wiley-Interscience, c2006 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Establishing a CGMP laboratory audit system [[electronic resource] ] : a practical guide / / David M. Bliesner
| Establishing a CGMP laboratory audit system [[electronic resource] ] : a practical guide / / David M. Bliesner |
| Autore | Bliesner David M |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley-Interscience, c2006 |
| Descrizione fisica | 1 online resource (295 p.) |
| Disciplina |
343.7307/86151
542.1 |
| Soggetto topico |
Pharmaceutical industry - United States
Drugs - Law and legislation - United States |
| Soggetto non controllato | Current Good Manufacturing Practices |
| ISBN |
1-280-44808-3
9786610448081 0-470-23938-7 0-471-78478-8 0-471-78477-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 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. |
| Record Nr. | UNINA-9910830871703321 |
|
Bliesner David M
|
||
| Hoboken, N.J., : Wiley-Interscience, c2006 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Establishing a CGMP laboratory audit system : a practical guide / / David M. Bliesner
| Establishing a CGMP laboratory audit system : a practical guide / / David M. Bliesner |
| Autore | Bliesner David M |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley-Interscience, c2006 |
| Descrizione fisica | 1 online resource (295 p.) |
| Disciplina | 343.7307/86151 |
| Soggetto topico |
Pharmaceutical industry - United States
Drugs - Law and legislation - United States |
| ISBN |
9786610448081
9781280448089 1280448083 9780470239384 0470239387 9780471784784 0471784788 9780471784777 047178477X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 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. |
| Record Nr. | UNINA-9911020121703321 |
|
Bliesner David M
|
||
| Hoboken, N.J., : Wiley-Interscience, c2006 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Validating chromatographic methods [[electronic resource] ] : a practical guide / / David M. Bliesner
| Validating chromatographic methods [[electronic resource] ] : a practical guide / / David M. Bliesner |
| Autore | Bliesner David M |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley, c2006 |
| Descrizione fisica | 1 online resource (301 p.) |
| Disciplina |
543.8
543/.8 |
| Soggetto topico |
Chromatographic analysis - Validity
Science - Methodology |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-64898-8
9786610648986 0-470-04220-6 0-470-04219-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
VALIDATING CHROMATOGRAPHIC METHODS; CONTENTS; PREFACE; 1. OVERVIEW OF METHODS VALIDATION; 2. COMPONENTS OF METHODS VALIDATION; 3. STEP 1: METHOD EVALUATION AND FURTHER DEVELOPMENT; 4. STEP 2: FINAL METHOD DEVELOPMENT AND TRIAL METHODS VALIDATION; 5. STEP 3: FORMAL METHODS VALIDATION AND REPORT GENERATION; 6. STEP 4: FORMAL DATA REVIEW AND REPORT ISSUANCE; 7. SUMMARY; APPENDICES; I. GLOSSARY OF METHODS VALIDATION TERMS; II. TEMPLATE FOR AN EXAMPLE METHODS VALIDATION STANDARD OPERATING PROCEDURE (SOP); III. TEMPLATE FOR AN EXAMPLE END-USER REQUIREMENTS QUESTIONNAIRE
IV. TEMPLATE FOR AN EXAMPLE METHOD REVIEW CHECKLISTV. TEMPLATE FOR AN EXAMPLE STANDARD TEST METHOD; VI. TEMPLATE FOR AN EXAMPLE METHODS VALIDATION PROTOCOL; VII. TEMPLATE FOR AN EXAMPLE METHODS VALIDATION REPORT; REFERENCES; INDEX |
| Record Nr. | UNINA-9910143416803321 |
|
Bliesner David M
|
||
| Hoboken, N.J., : Wiley, c2006 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Validating chromatographic methods [[electronic resource] ] : a practical guide / / David M. Bliesner
| Validating chromatographic methods [[electronic resource] ] : a practical guide / / David M. Bliesner |
| Autore | Bliesner David M |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley, c2006 |
| Descrizione fisica | 1 online resource (301 p.) |
| Disciplina |
543.8
543/.8 |
| Soggetto topico |
Chromatographic analysis - Validity
Science - Methodology |
| ISBN |
1-280-64898-8
9786610648986 0-470-04220-6 0-470-04219-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
VALIDATING CHROMATOGRAPHIC METHODS; CONTENTS; PREFACE; 1. OVERVIEW OF METHODS VALIDATION; 2. COMPONENTS OF METHODS VALIDATION; 3. STEP 1: METHOD EVALUATION AND FURTHER DEVELOPMENT; 4. STEP 2: FINAL METHOD DEVELOPMENT AND TRIAL METHODS VALIDATION; 5. STEP 3: FORMAL METHODS VALIDATION AND REPORT GENERATION; 6. STEP 4: FORMAL DATA REVIEW AND REPORT ISSUANCE; 7. SUMMARY; APPENDICES; I. GLOSSARY OF METHODS VALIDATION TERMS; II. TEMPLATE FOR AN EXAMPLE METHODS VALIDATION STANDARD OPERATING PROCEDURE (SOP); III. TEMPLATE FOR AN EXAMPLE END-USER REQUIREMENTS QUESTIONNAIRE
IV. TEMPLATE FOR AN EXAMPLE METHOD REVIEW CHECKLISTV. TEMPLATE FOR AN EXAMPLE STANDARD TEST METHOD; VI. TEMPLATE FOR AN EXAMPLE METHODS VALIDATION PROTOCOL; VII. TEMPLATE FOR AN EXAMPLE METHODS VALIDATION REPORT; REFERENCES; INDEX |
| Record Nr. | UNINA-9910829868003321 |
|
Bliesner David M
|
||
| Hoboken, N.J., : Wiley, c2006 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Validating chromatographic methods : a practical guide / / David M. Bliesner
| Validating chromatographic methods : a practical guide / / David M. Bliesner |
| Autore | Bliesner David M |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley, c2006 |
| Descrizione fisica | 1 online resource (301 p.) |
| Disciplina | 543/.8 |
| Soggetto topico |
Chromatographic analysis - Validity
Science - Methodology |
| ISBN |
9786610648986
9781280648984 1280648988 9780470042205 0470042206 9780470042199 0470042192 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
VALIDATING CHROMATOGRAPHIC METHODS; CONTENTS; PREFACE; 1. OVERVIEW OF METHODS VALIDATION; 2. COMPONENTS OF METHODS VALIDATION; 3. STEP 1: METHOD EVALUATION AND FURTHER DEVELOPMENT; 4. STEP 2: FINAL METHOD DEVELOPMENT AND TRIAL METHODS VALIDATION; 5. STEP 3: FORMAL METHODS VALIDATION AND REPORT GENERATION; 6. STEP 4: FORMAL DATA REVIEW AND REPORT ISSUANCE; 7. SUMMARY; APPENDICES; I. GLOSSARY OF METHODS VALIDATION TERMS; II. TEMPLATE FOR AN EXAMPLE METHODS VALIDATION STANDARD OPERATING PROCEDURE (SOP); III. TEMPLATE FOR AN EXAMPLE END-USER REQUIREMENTS QUESTIONNAIRE
IV. TEMPLATE FOR AN EXAMPLE METHOD REVIEW CHECKLISTV. TEMPLATE FOR AN EXAMPLE STANDARD TEST METHOD; VI. TEMPLATE FOR AN EXAMPLE METHODS VALIDATION PROTOCOL; VII. TEMPLATE FOR AN EXAMPLE METHODS VALIDATION REPORT; REFERENCES; INDEX |
| Record Nr. | UNINA-9911018975203321 |
|
Bliesner David M
|
||
| Hoboken, N.J., : Wiley, c2006 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||