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ASHP's safety and quality pearls [[electronic resource] /] / [edited by] Melodi J. McNeil
| ASHP's safety and quality pearls [[electronic resource] /] / [edited by] Melodi J. McNeil |
| Pubbl/distr/stampa | Bethesda, Md., : American Society of Health-System Pharmacists, c2008 |
| Descrizione fisica | 1 online resource (181 p.) |
| Disciplina | 362.17/82 |
| Altri autori (Persone) | McNeilMelodi J |
| Collana | ASHP's Safety and Quality Pearls |
| Soggetto topico |
Hospital pharmacies - Quality control
Drugs - Standards |
| Soggetto genere / forma | Electronic books. |
| ISBN | 1-58528-312-6 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | pt. 1. National standards and guidelines -- pt. 2. Technology and devices -- pt. 3. Tools. |
| Record Nr. | UNINA-9910464395603321 |
| Bethesda, Md., : American Society of Health-System Pharmacists, c2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Bulletin of WHO . Vol. 92 No. 09 2014. / / by World Health Organization
| Bulletin of WHO . Vol. 92 No. 09 2014. / / by World Health Organization |
| Pubbl/distr/stampa | London, England : , : World Health Organization, , [2014] |
| Descrizione fisica | 1 online resource (80 p.) |
| Disciplina | 615.105 |
| Soggetto topico |
Drugs - Standards
Pharmaceutical industry |
| ISBN | 92-4-069241-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
""BULLETIN OF THE WORLD HEALTH ORGANIZATION - September 2014 ""; ""BULLETIN OF THE WORLD HEALTH ORGANIZATION - September 2014 ""; ""MASTHEAD""; ""MASTHEAD""; ""In this month�s Bulletin""; ""In this month?s Bulletin""; ""Editorials""; ""Editorials""; ""The 2014 Ebola outbreak: ethical use of unregistered interventions""; ""The 2014 Ebola outbreak: ethical use of unregistered interventions""; ""Towards the world we want""; ""Towards the world we want""; ""News""; ""News""; ""Public health round-up""; ""Public health round-up""; ""China enters the global vaccine market ""
""China enters the global vaccine market """"Most people can stay fit and healthy into old age""; ""Most people can stay fit and healthy into old age""; ""Research""; ""Research""; ""Effect of the economic recession on pharmaceutical policy and medicine sales in eight European countries""; ""Effect of the economic recession on pharmaceutical policy and medicine sales in eight European countries""; ""Adverse childhood experiences and associations with health-harming behaviours in young adults: surveys in eight eastern European countries"" ""Adverse childhood experiences and associations with health-harming behaviours in young adults: surveys in eight eastern European countries""""Hand, foot and mouth disease in China: evaluating an automated system for the detection of outbreaks""; ""Hand, foot and mouth disease in China: evaluating an automated system for the detection of outbreaks""; ""Childhood diarrhoeal deaths in seven low- and middle-income countries ""; ""Childhood diarrhoeal deaths in seven low- and middle-income countries ""; ""Pollicy & practice""; ""Pollicy & practice"" ""Proposed declassification of disease categories related to sexual orientation in the International Statistical Classification of Diseases and Related Health Problems (ICD-11)""""Proposed declassification of disease categories related to sexual orientation in the International Statistical Classification of Diseases and Related Health Problems (ICD-11)""; ""Lessons from the field""; ""Lessons from the field""; ""Mobile clinics for antiretroviral therapy in rural Mozambique""; ""Mobile clinics for antiretroviral therapy in rural Mozambique"" ""Challenges encountered using standard vector control measures for dengue in Boa Vista, Brazil""""Challenges encountered using standard vector control measures for dengue in Boa Vista, Brazil""; ""Sampling at community level by using satellite imagery and geographical analysis""; ""Sampling at community level by using satellite imagery and geographical analysis""; ""Perspectives""; ""Perspectives""; ""The Global Vaccine Safety Initiative: enhancing vaccine pharmacovigilance capacity at country level"" ""The Global Vaccine Safety Initiative: enhancing vaccine pharmacovigilance capacity at country level"" |
| Record Nr. | UNINA-9910787057903321 |
| London, England : , : World Health Organization, , [2014] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Bulletin of WHO . Vol. 92 No. 09 2014. / / by World Health Organization
| Bulletin of WHO . Vol. 92 No. 09 2014. / / by World Health Organization |
| Pubbl/distr/stampa | London, England : , : World Health Organization, , [2014] |
| Descrizione fisica | 1 online resource (80 p.) |
| Disciplina | 615.105 |
| Soggetto topico |
Drugs - Standards
Pharmaceutical industry |
| ISBN | 92-4-069241-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
""BULLETIN OF THE WORLD HEALTH ORGANIZATION - September 2014 ""; ""BULLETIN OF THE WORLD HEALTH ORGANIZATION - September 2014 ""; ""MASTHEAD""; ""MASTHEAD""; ""In this month�s Bulletin""; ""In this month?s Bulletin""; ""Editorials""; ""Editorials""; ""The 2014 Ebola outbreak: ethical use of unregistered interventions""; ""The 2014 Ebola outbreak: ethical use of unregistered interventions""; ""Towards the world we want""; ""Towards the world we want""; ""News""; ""News""; ""Public health round-up""; ""Public health round-up""; ""China enters the global vaccine market ""
""China enters the global vaccine market """"Most people can stay fit and healthy into old age""; ""Most people can stay fit and healthy into old age""; ""Research""; ""Research""; ""Effect of the economic recession on pharmaceutical policy and medicine sales in eight European countries""; ""Effect of the economic recession on pharmaceutical policy and medicine sales in eight European countries""; ""Adverse childhood experiences and associations with health-harming behaviours in young adults: surveys in eight eastern European countries"" ""Adverse childhood experiences and associations with health-harming behaviours in young adults: surveys in eight eastern European countries""""Hand, foot and mouth disease in China: evaluating an automated system for the detection of outbreaks""; ""Hand, foot and mouth disease in China: evaluating an automated system for the detection of outbreaks""; ""Childhood diarrhoeal deaths in seven low- and middle-income countries ""; ""Childhood diarrhoeal deaths in seven low- and middle-income countries ""; ""Pollicy & practice""; ""Pollicy & practice"" ""Proposed declassification of disease categories related to sexual orientation in the International Statistical Classification of Diseases and Related Health Problems (ICD-11)""""Proposed declassification of disease categories related to sexual orientation in the International Statistical Classification of Diseases and Related Health Problems (ICD-11)""; ""Lessons from the field""; ""Lessons from the field""; ""Mobile clinics for antiretroviral therapy in rural Mozambique""; ""Mobile clinics for antiretroviral therapy in rural Mozambique"" ""Challenges encountered using standard vector control measures for dengue in Boa Vista, Brazil""""Challenges encountered using standard vector control measures for dengue in Boa Vista, Brazil""; ""Sampling at community level by using satellite imagery and geographical analysis""; ""Sampling at community level by using satellite imagery and geographical analysis""; ""Perspectives""; ""Perspectives""; ""The Global Vaccine Safety Initiative: enhancing vaccine pharmacovigilance capacity at country level"" ""The Global Vaccine Safety Initiative: enhancing vaccine pharmacovigilance capacity at country level"" |
| Record Nr. | UNINA-9910807728603321 |
| London, England : , : World Health Organization, , [2014] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
The certified pharmaceutical GMP professional handbook. / / Mark Allen Durivage, editor
| The certified pharmaceutical GMP professional handbook. / / Mark Allen Durivage, editor |
| Edizione | [Second edition.] |
| Pubbl/distr/stampa | Milwaukee, Wisconsin : , : ASQ Quality Press, , 2016 |
| Descrizione fisica | 1 online resource (516 pages) : illustrations |
| Disciplina | 615.1/9 |
| Soggetto topico |
Drug development
Drugs - Standards Pharmaceutical industry - Quality control |
| Soggetto genere / forma | Electronic books. |
| ISBN | 1-951058-89-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910467611103321 |
| Milwaukee, Wisconsin : , : ASQ Quality Press, , 2016 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
The certified pharmaceutical GMP professional handbook. / / Mark Allen Durivage, editor
| The certified pharmaceutical GMP professional handbook. / / Mark Allen Durivage, editor |
| Edizione | [Second edition.] |
| Pubbl/distr/stampa | Milwaukee, Wisconsin : , : ASQ Quality Press, , 2016 |
| Descrizione fisica | 1 online resource (516 pages) : illustrations |
| Disciplina | 615.1/9 |
| Soggetto topico |
Drug development
Drugs - Standards Pharmaceutical industry - Quality control |
| ISBN |
1-951058-90-9
1-951058-89-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910794296003321 |
| Milwaukee, Wisconsin : , : ASQ Quality Press, , 2016 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
The certified pharmaceutical GMP professional handbook. / / Mark Allen Durivage, editor
| The certified pharmaceutical GMP professional handbook. / / Mark Allen Durivage, editor |
| Edizione | [Second edition.] |
| Pubbl/distr/stampa | Milwaukee, Wisconsin : , : ASQ Quality Press, , 2016 |
| Descrizione fisica | 1 online resource (516 pages) : illustrations |
| Disciplina | 615.1/9 |
| Soggetto topico |
Drug development
Drugs - Standards Pharmaceutical industry - Quality control |
| ISBN |
1-951058-90-9
1-951058-89-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910813363003321 |
| Milwaukee, Wisconsin : , : ASQ Quality Press, , 2016 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Ensuring drug quality in global health programs [[electronic resource] /] / [David Gootnick, Marcia Crosse]
| Ensuring drug quality in global health programs [[electronic resource] /] / [David Gootnick, Marcia Crosse] |
| Autore | Gootnick David |
| Pubbl/distr/stampa | Washington, DC : , : U.S. Govt. Accountability Office, , [2012] |
| Descrizione fisica | 1 online resource (27 pages) : color illustrations |
| Altri autori (Persone) | CrosseMarcia |
| Soggetto topico |
World health
Drugs - Standards Drug factories - Quality control |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Global health |
| Record Nr. | UNINA-9910703501403321 |
Gootnick David
|
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| Washington, DC : , : U.S. Govt. Accountability Office, , [2012] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
The FDA and worldwide current good manufacturing practices and quality system requirements guidebook for finished pharmaceuticals / / José Rodríguez-Pérez
| The FDA and worldwide current good manufacturing practices and quality system requirements guidebook for finished pharmaceuticals / / José Rodríguez-Pérez |
| Autore | Rodríguez Pérez José <1961-> |
| Pubbl/distr/stampa | Milwaukee, Wisconsin : , : ASQ Quality Press, , [2014] |
| Descrizione fisica | 1 online resource (391 pages) |
| Disciplina | 338.476151 |
| Soggetto topico |
Pharmaceutical industry - United States - Quality control
Pharmaceutical industry - Production standards - United States Drugs - Standards |
| ISBN |
0-87389-828-1
0-87389-829-X 1-68015-784-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910797541903321 |
|
Rodríguez Pérez José <1961->
|
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| Milwaukee, Wisconsin : , : ASQ Quality Press, , [2014] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
The FDA and worldwide current good manufacturing practices and quality system requirements guidebook for finished pharmaceuticals / / José Rodríguez-Pérez
| The FDA and worldwide current good manufacturing practices and quality system requirements guidebook for finished pharmaceuticals / / José Rodríguez-Pérez |
| Autore | Rodríguez Pérez José <1961-> |
| Pubbl/distr/stampa | Milwaukee, Wisconsin : , : ASQ Quality Press, , [2014] |
| Descrizione fisica | 1 online resource (391 pages) |
| Disciplina | 338.476151 |
| Soggetto topico |
Pharmaceutical industry - United States - Quality control
Pharmaceutical industry - Production standards - United States Drugs - Standards |
| ISBN |
0-87389-828-1
0-87389-829-X 1-68015-784-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910814801203321 |
|
Rodríguez Pérez José <1961->
|
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| Milwaukee, Wisconsin : , : ASQ Quality Press, , [2014] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
GMP-Qualifizierung und Validierung von Wirkstoffanlagen ein Leitfaden für die Praxis [[electronic resource] /] / Ralf Gengenbach
| GMP-Qualifizierung und Validierung von Wirkstoffanlagen ein Leitfaden für die Praxis [[electronic resource] /] / Ralf Gengenbach |
| Autore | Gengenbach Ralf <1960-> |
| Pubbl/distr/stampa | Weinheim, : Wiley-VCH, c2008 |
| Descrizione fisica | 1 online resource (494 p.) |
| Disciplina | 615.19002184 |
| Soggetto topico |
Drugs - Standards
Materia medica, Vegetable |
| Soggetto genere / forma | Electronic books. |
| ISBN |
3-527-65998-6
1-282-02169-9 9786612021695 3-527-62627-1 3-527-62628-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | ger |
| Nota di contenuto |
GMP-Qualifizierung und Validierung von Wirkstoffanlagen; Geleitwort Storhas; Geleitwort Behrendt; Inhaltsverzeichnis; Vorwort; Abkürzungsverzeichnis; 1 Einführung; 2 GMP-Grundlagen; 2.1 Der Begriff GMP; 2.2 Geltungsbereich von GMP; 2.2.1 GMP - für welche Produkte?; 2.2.2 GMP - ab welcher Entwicklungsstufe?; 2.2.3 GMP - ab welcher Verfahrensstufe?; 2.2.4 Zusammenfassung; 2.3 GMP-Regelwerke; 2.3.1 Historische Entwicklung; 2.3.2 GMP-Regeln der WHO; 2.3.3 GMP-Regeln der Pharmaceutical Inspection Convention (PIC bzw. PIC/S); 2.3.4 GMP-Regeln der EU; 2.3.5 GMP-Regeln der USA
2.3.5.1 FDA Guidance documents2.3.5.2 FDA Guide to Inspections; 2.3.5.3 FDA Compliance Program Guidance Manuals - CPGM; 2.3.5.4 FDA Compliance Policy Guides - CPG; 2.3.5.5 FDA Human Drug cGMP Notes; 2.3.6 GMP-Regeln in Asien; 2.3.7 Die Wirkstoffproblematik; 2.3.7.1 Wirkstoffe in den USA; 2.3.7.2 Wirkstoffe in der BRD; 2.3.8 GMP für Hilfsstoffe, Kosmetika und andere Produkte; 2.3.8.1 Hilfsstoffe; 2.3.8.2 Kosmetikprodukte; 2.3.8.3 Lebensmittel und Lebensmittelzusatzstoffe; 2.3.8.4 Futtermittel und Futtermittelzusatzstoffe; 2.3.9 Harmonisierte GMP-Regeln, ICH 2.3.10 Verbindlichkeit von GMP-Regeln2.4 GMP-Inhalte und Kernforderungen; 2.5 Weitergehende Interpretationen; 2.6 Inspektionen und Zertifizierung; 2.6.1 GMP-Inspektionen; 2.6.2 GMP-Zertifikate; 3 Grundlagen der Validierung; 3.1 Rechtsgrundlagen; 3.2 Begriffe und Definitionen; 3.2.1 Validierung; 3.2.2 Elemente der Validierung; 3.2.3 Methoden der Validierung; 3.2.4 Revalidierung; 3.3 Anforderungen aus den Regelwerken (WHO, FDA, PIC etc.); 3.3.1 FDA-Anforderungen an die Validierung; 3.3.2 WHO-Anforderungen an die Validierung; 3.3.3 PIC/S-Anforderungen an die Validierung 4.4.3 Abschließende Bemerkung4.5 Das Validierungsteam; 4.5.1 Validierungsverantwortlicher; 4.5.2 Validierungsteam; 4.5.3 Validierungskoordinator; 4.5.4 Allgemeine Aspekte; 4.6 Der Validierungsmasterplan; 4.6.1 Grundlegende Forderungen; 4.6.2 Der Validierungsmasterordner; 4.6.2.1 Aufbau und Inhalt; 4.6.2.2 Projektspezifischer Masterplan; 4.6.2.3 Projektpläne Qualifizierung und Validierung; 4.6.2.4 Pflege und Fortführung; 4.7 Die Risikoanalyse; 4.7.1 Begriffe und Bedeutung; 4.7.2 Methoden der Risikoanalyse; 4.7.2.1 Übersicht über die gängigsten Methoden; 4.7.2.2 Die FMEA-Methode 4.7.2.3 Die HACCP-Methode |
| Record Nr. | UNINA-9910146098903321 |
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Gengenbach Ralf <1960->
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| Weinheim, : Wiley-VCH, c2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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