04147oam 2200577 450 991055513690332120220808193447.01-119-35612-11-119-35619-91-119-35611-3(CKB)4950000000162532(OCoLC)1127947568(MiAaPQ)EBC5977949(EXLCZ)99495000000016253220191211h20202020 uy 0engurcn#||||||||txtrdacontentcrdamediacrrdacarrierPharmaceutical 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, SwitzerlandHoboken, NJ :Wiley,2020.©20201 online resource (xxxv, 546 pages) illustrations1 online resource (xxxv, 546 pages) illustrations1-119-35607-5 Print version: Pharmaceutical microbiological quality assurance and control. First edition. Hoboken, NJ : Wiley, 2019 9781119356073 1119356075 (DLC) 2019024995 (OCoLC)1039613996 Includes bibliographical references and index.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."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"--.Pharmaceutical technologyStandardsMicrobiological TechniquesstandardsMicrobiological PhenomenaDrugsTestingfast(OCoLC)fst00898940Pharmaceutical chemistryfast(OCoLC)fst01060115Electronic books.Pharmaceutical technologyStandards.Microbiological Techniquesstandards.Microbiological Phenomena.DrugsTesting.Pharmaceutical chemistry.615.19Roesti David1973-,Goverde Marcel1967-,MiAaPQMiAaPQMiAaPQBOOK9910555136903321Pharmaceutical microbiological quality assurance and control2815510UNINA