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

• Pubblicazione: Hoboken, NJ : , : Wiley, , 2020; ©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
• Persona (resp. second.): RoestiDavid <1973-, >; GoverdeMarcel <1967-, >
• Nota di bibliografia: Includes bibliographical references and index.
• 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.
• 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"--.
• Titolo autorizzato: Pharmaceutical microbiological quality assurance and control
• ISBN: 1-119-35612-1; 1-119-35619-9; 1-119-35611-3
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910830890003321
• Lo trovi qui: Univ. Federico II