LEADER 04147oam 2200577 450 001 9910555136903321 005 20220808193447.0 010 $a1-119-35612-1 010 $a1-119-35619-9 010 $a1-119-35611-3 035 $a(CKB)4950000000162532 035 $a(OCoLC)1127947568 035 $a(MiAaPQ)EBC5977949 035 $a(EXLCZ)994950000000162532 100 $a20191211h20202020 uy 0 101 0 $aeng 135 $aurcn#|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aPharmaceutical microbiological quality assurance and control $epractical guide for non-sterile manufacturing /$fedited by David Roesti, Novartis Pharma Stein AG, Switzerland, Marcel Goverde, MGP Consulting GmbH, Switzerland 210 1$aHoboken, NJ :$cWiley,$d2020. 210 4$dİ2020 215 $a1 online resource (xxxv, 546 pages) $cillustrations 215 $a1 online resource (xxxv, 546 pages) $cillustrations 311 1 $a1-119-35607-5 311 08$aPrint version: Pharmaceutical microbiological quality assurance and control. First edition. Hoboken, NJ : Wiley, 2019 9781119356073 1119356075 (DLC) 2019024995 (OCoLC)1039613996 320 $aIncludes bibliographical references and index. 327 $aMicrobiological 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. 330 $a"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"--. 606 $aPharmaceutical technology$xStandards 606 $aMicrobiological Techniques$xstandards 606 $aMicrobiological Phenomena 606 $aDrugs$xTesting$2fast$3(OCoLC)fst00898940 606 $aPharmaceutical chemistry$2fast$3(OCoLC)fst01060115 608 $aElectronic books. 615 0$aPharmaceutical technology$xStandards. 615 2$aMicrobiological Techniques$xstandards. 615 2$aMicrobiological Phenomena. 615 7$aDrugs$xTesting. 615 7$aPharmaceutical chemistry. 676 $a615.19 702 $aRoesti$b David$f1973-, 702 $aGoverde$b Marcel$f1967-, 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910555136903321 996 $aPharmaceutical microbiological quality assurance and control$92815510 997 $aUNINA