Global Regulatory Perspectives on Quality by Design in Pharma Manufacturing

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dc.contributor.authorAksu, Buket
dc.contributor.authorYeğen, Yegen Gizem
dc.date.accessioned2025-02-06T18:01:21Z
dc.date.available2025-02-06T18:01:21Z
dc.date.issued2019
dc.departmentAltınbaş Üniversitesien_US
dc.description.abstractThe legislations have almost frozen the processes used in pharmaceutical manufacturing overtime. Even after the receipt of drugs’ permits/certificates, even a small change in the method of manufacturing of medicines requires examination and approval of health authority, resulting in time and paperwork. The Food and Drug Administration (FDA) is at the forefront of work in the field of “Quality by Design (QbD), " which implements regulatory intelligence to modernize the understanding and control of pharma manufacturing processes. The applications performed within the QbD approach, based on scientific data and with previous knowledge and experiences, are now part of the process for change with the flexibility of real-time release. As a result of these changes, the process is proved to function and the confidence in the system is increased. © 2019 Elsevier Inc. All rights reserved.en_US
dc.identifier.doi10.1016/B978-0-12-815799-2.00002-2
dc.identifier.endpage41en_US
dc.identifier.isbn978-012815799-2
dc.identifier.scopus2-s2.0-85108086077
dc.identifier.startpage19en_US
dc.identifier.urihttps://doi.org/10.1016/B978-0-12-815799-2.00002-2
dc.identifier.urihttps://hdl.handle.net/20.500.12939/5344
dc.indekslendigikaynakScopus
dc.language.isoenen_US
dc.publisherElsevieren_US
dc.relation.ispartofPharmaceutical Quality by Design: Principles and Applicationsen_US
dc.relation.publicationcategoryKitap Bölümü - Uluslararasıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.snmzKA_Scopus_20250206
dc.subjectICHen_US
dc.subjectLegislationen_US
dc.subjectPharmaceutical manufacturingen_US
dc.subjectQuality by designen_US
dc.subjectReal-time releaseen_US
dc.titleGlobal Regulatory Perspectives on Quality by Design in Pharma Manufacturingen_US
dc.typeBook Parten_US

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