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Pharmaceutical microbiological quality assurance and control : practical guide for non-sterile manufacturing / / edited by David Roesti, Novartis Pharma Stein AG, Switzerland, Marcel Goverde, MGP Consulting GmbH, Switzerland
| Pharmaceutical microbiological quality assurance and control : practical guide for non-sterile manufacturing / / edited by David Roesti, Novartis Pharma Stein AG, Switzerland, Marcel Goverde, MGP Consulting GmbH, Switzerland |
| Pubbl/distr/stampa | Hoboken, NJ : , : Wiley, , 2020 |
| Descrizione fisica | 1 online resource (xxxv, 546 pages) : illustrations |
| Disciplina | 615.19 |
| Soggetto topico |
Pharmaceutical technology - Standards
Microbiological Techniques - standards Microbiological Phenomena Drugs - Testing Pharmaceutical chemistry |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-119-35612-1
1-119-35619-9 1-119-35611-3 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Microbiological control strategy -- Microbial contamination risk assessment in non-sterile drug product manufacturing and risk mitigation -- Qualification of Microbiological laboratory personnel and equipment -- Introduction to culture media in pharmaceutical microbiology for non-sterile products -- Microbiological examination of non-sterile final dosage forms and raw material including acceptance criteria and testing frequency -- Microbial requirements and testing of primary packaging -- Utilities design and testing -- Microbiological Environmental Monitoring -- Identification of microorganisms -- Calculating alert levels and trending of microbiological data -- Exclusion of objectionable microorganisms from non-sterile pharmaceutical drug products -- Data integrity and microbiological excursion handling -- Rapid microbiological methods -- Validation of a rapid microbiological method for the microbiological examination of non-sterile and non-filterable drug products, APIs and excipients -- An Ex-Regulator's View of the Microbiology QA/QC Functions in the US Pharmaceutical Industries -- Practical guide for microbiological QA/QC of non-sterile pharmaceuticals manufacturing for EU -- Which microbiological tests can better be performed in-house and what can be easily outsourced. |
| Record Nr. | UNINA-9910555136903321 |
| Hoboken, NJ : , : Wiley, , 2020 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Pharmaceutical microbiological quality assurance and control : practical guide for non-sterile manufacturing / / edited by David Roesti, Novartis Pharma Stein AG, Switzerland, Marcel Goverde, MGP Consulting GmbH, Switzerland
| Pharmaceutical microbiological quality assurance and control : practical guide for non-sterile manufacturing / / edited by David Roesti, Novartis Pharma Stein AG, Switzerland, Marcel Goverde, MGP Consulting GmbH, Switzerland |
| Pubbl/distr/stampa | Hoboken, NJ : , : Wiley, , 2020 |
| Descrizione fisica | 1 online resource (xxxv, 546 pages) : illustrations |
| Disciplina | 615.19 |
| Soggetto topico |
Pharmaceutical technology - Standards
Microbiological Techniques - standards Microbiological Phenomena Drugs - Testing Pharmaceutical chemistry |
| ISBN |
1-119-35612-1
1-119-35619-9 1-119-35611-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Microbiological control strategy -- Microbial contamination risk assessment in non-sterile drug product manufacturing and risk mitigation -- Qualification of Microbiological laboratory personnel and equipment -- Introduction to culture media in pharmaceutical microbiology for non-sterile products -- Microbiological examination of non-sterile final dosage forms and raw material including acceptance criteria and testing frequency -- Microbial requirements and testing of primary packaging -- Utilities design and testing -- Microbiological Environmental Monitoring -- Identification of microorganisms -- Calculating alert levels and trending of microbiological data -- Exclusion of objectionable microorganisms from non-sterile pharmaceutical drug products -- Data integrity and microbiological excursion handling -- Rapid microbiological methods -- Validation of a rapid microbiological method for the microbiological examination of non-sterile and non-filterable drug products, APIs and excipients -- An Ex-Regulator's View of the Microbiology QA/QC Functions in the US Pharmaceutical Industries -- Practical guide for microbiological QA/QC of non-sterile pharmaceuticals manufacturing for EU -- Which microbiological tests can better be performed in-house and what can be easily outsourced. |
| Record Nr. | UNINA-9910830890003321 |
| Hoboken, NJ : , : Wiley, , 2020 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||