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Record Nr. |
UNINA9910830890003321 |
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Titolo |
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 |
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Pubbl/distr/stampa |
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Hoboken, NJ : , : Wiley, , 2020 |
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©2020 |
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ISBN |
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1-119-35612-1 |
1-119-35619-9 |
1-119-35611-3 |
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Descrizione fisica |
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1 online resource (xxxv, 546 pages) : illustrations |
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Disciplina |
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Soggetti |
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Pharmaceutical technology - Standards |
Microbiological Techniques - standards |
Microbiological Phenomena |
Drugs - Testing |
Pharmaceutical chemistry |
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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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Nota di bibliografia |
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Includes bibliographical references and index. |
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Nota di contenuto |
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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 |
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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. |
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Sommario/riassunto |
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"This book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. It covers state-of-the-art microbiology quality assurance and control (QA / QC) tests as well as risk mitigation strategies so that the reader can implement these methodologies in a facility or laboratory to meet microbiology current good manufacturing practices (cGMPs). Also, the authors discuss developments in microbiological testing technology. They share their long experience in practicing microbiological QA/QC in large multinational pharmaceutical companies and present real-life complex cases involving tough decision making"--. |
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