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[1]《藥品生產質量管理規範》(2010年修訂)及附錄;
[2] PDA Technical Report No.40,Sterilizing Filtration of Gases;
[3] PDA Technical Report No.26 Revised 2008,Sterilizing Filtration of Liquids;
[4] USFDA Guidance for Industry,Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice,2004;
[5] EU Guidelines to Good Manufacturing Practice,Annex 1 Manufacture of Sterile Medicinal Products,2008。