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 | ||
![]() | ||
Lo trovi qui: Univ. Federico II | ||
|
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 | ||
![]() | ||
Lo trovi qui: Univ. Federico II | ||
|
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-9910841397903321 |
Bliesner David M
![]() |
||
Hoboken, N.J., : Wiley-Interscience, c2006 | ||
![]() | ||
Lo trovi qui: Univ. Federico II | ||
|
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 | ||
![]() | ||
Lo trovi qui: Univ. Federico II | ||
|
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 | ||
![]() | ||
Lo trovi qui: Univ. Federico II | ||
|
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-9910840587503321 |
Bliesner David M
![]() |
||
Hoboken, N.J., : Wiley, c2006 | ||
![]() | ||
Lo trovi qui: Univ. Federico II | ||
|