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[null,"1.","Record Nr.",null,"UNISA990001227200203316"]
[null,null,"Autore",null,"APEL, Willi"]
[null,null,"Titolo",null,"The history of keyboard music to 1700 / Willi Apel ; translated and revised by Hans Tischler"]
[null,null,"Pubbl/distr/stampa",null,"Bloomington : Indiana University Press, 1972"]
[null,null,"Descrizione fisica",null,"XVI, 977 p. : ill. ; 23 cm"]
[null,null,"Soggetti",null,"Strumenti a tastiera - Storia - Origini-1700"]
[null,null,"Collocazione",null,"XIII.3.C. 94(VII-M-174)"]
[null,null,"Lingua di pubblicazione",null,"Inglese"]
[null,null,"Formato",null,"Materiale a stampa"]
[null,null,null,"Livello bibliografico","Monografia"]
[null,"2.","Record Nr.",null,"UNINA9910555136903321"]
[null,null,"Titolo",null,"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"]
[null,null,"Pubbl/distr/stampa",null,"Hoboken, NJ : , : Wiley, , 2020"]
[{"$nulls":4},"©2020"]
[null,null,"ISBN",null,"1-119-35612-1"]
[{"$nulls":4},"1-119-35619-9"]
[{"$nulls":4},"1-119-35611-3"]
[null,null,"Descrizione fisica",null,"1 online resource (xxxv, 546 pages) : illustrations"]
[null,null,"Disciplina",null,"615.19"]
[null,null,"Soggetti",null,"Pharmaceutical technology - Standards"]
[{"$nulls":4},"Microbiological Techniques - standards"]
[{"$nulls":4},"Microbiological Phenomena"]
[{"$nulls":4},"Drugs - Testing"]
[{"$nulls":4},"Pharmaceutical chemistry"]
[{"$nulls":4},"Electronic books."]
[null,null,"Lingua di pubblicazione",null,"Inglese"]
[null,null,"Formato",null,"Materiale a stampa"]
[null,null,null,"Livello bibliografico","Monografia"]
[null,null,null,"Nota di bibliografia","Includes bibliographical references and index."]
[null,null,"Nota di contenuto",null,"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 "]
[{"$nulls":4},"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."]
[null,null,null,"Sommario/riassunto","\"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\"--."]