|
1.行政院衛生署(2011),國際醫藥品稽查協約組織(PIC/S)藥品優良製造規範指導手冊,行政院衛生署。 2.行政院衛生署(2001),清潔確效作業指導手冊,行政院衛生署。 3.林文貞(2005),「藥品優良製造確效作業和優良實驗操作之精神」,在醫藥基因生物技術教學資源中心主編,特定標的之新藥開發,第11章,頁146-147。 4.財團法人醫藥工業技術發展中心(2005),台灣現行藥品優良製造規範-清潔確效作業指導手冊,財團法人醫藥工業技術發展中心。 5.黃建才(1996),藥劑學,黎明書局,台中,頁204-254。 6.經濟部工業局(2000),清潔方法確效關鍵因素研討會講義,經濟部工業局,頁47。 7.Canada Health Products and Food Branch Inspectorate (2000). Good Manufacturing Practices - Cleaning Validation Guidelines, Canada Health Products and Food Branch Inspectorate. 8.Mendenhall, D. W. (1989). Cleaning Validation, Drug Development and Industrial Pharmacy. 9.FDA (1993). Guide to Inspectors of Validation of Cleaning Procedures, FDA. 10.International Organization for Standardization (1999). ISO 14644-1:1999, Cleanrooms and Associated Controlled Environments - Part 1: Classification of Air Cleanliness. 11.Cavallo, J. (1992). “Cleaning With Air-propelled Foam Media”, Material Performance, Feb. 12.Banner, M. (1989). Principles of Cleaning and Sanitizing, Diversey Corporation. 13.Blackmon, M. L. (date unknown). ”Cleaning Validation of Existing Products in Solid Dosage Processes,” Burroughs Wellcome, Oral Presentation. 14.Pharmaceutical Inspection Co-operation Scheme (2009). Guide to Good Manufacturing Practice for Medicinal Product Part II, PE 009-9, Geneva. 15.PMA (1986). Validation Concepts for Cleaning Methods Associated with Manufacture of Drug Products, PMA. 16.Harder, S. W. (1984). “TheValidation ofCleaning Procedures”, Pharmaceutical Techology, May. 17.Taylor, S.A. and Chapman, G., (1991). “Cleaning Pipelines Using High Pressure Water Jets”, Material Performance, September. 18.Whyte, W. (2001). Cleanroom Technology: Fundamentals of Design, Testing And Operation, John Wiley & Sons, West Sussex, England. 19.Boffa, W. (1991). “Automatic Pump Station Cleaning Eliminates Grease Nuisance”, Water Engineering and Management, January.
|