DESIGN OF FILL AND FINISH FACILITY FOR ACTIVE PHARMACEUTICAL INGREDIENTS (API)

Autor: NUUR LAILA KHAIRUDDIN, NORLIZA ABD. RAHMAN, NUR SYAFIQAH KAMARUDIN
Jazyk: angličtina
Rok vydání: 2016
Předmět:
Zdroj: Journal of Engineering Science and Technology, Vol 11, Iss 8, Pp 1135-1154 (2016)
Druh dokumentu: article
ISSN: 1823-4690
Popis: Fill and finish operations continue to be one of the most heavily outsourced activities in the biopharmaceutical manufacturing market today. There are a few aspects that need to be consider in outsource activities like logistic, storage condition, facility certification and audit as regulations and standards which the manufacturer should adhere. Risk would be greater and extra care should be taken when outsource from foreign fill and finish facility. Thus, the internal aseptic fill and finish facility with audit checklist will help to minimize the risk during logistic and storage and also minimize the cost for outsource fill and finish facility. The data collections are through survey and conceptual design with simulation as the execution part.
Databáze: Directory of Open Access Journals