3FDA. Sterile drug products produced by aseptic processing, guidance for industry [S]. 2004.
4Miller D. Evaluation of extractables from product-contact surfaces [J]. BioPharm Inter, 2002, 15 (12): 22-34.
5Weitzmann C. The use of model solvents for evaluating extractables from filters used to process pharmaceutical products [J]. Pharm Tech, 1997, 21 (4) : 72-99.
二级参考文献18
1EMA. EU guidelines to good manufacturing practice[ S]. Annex 15, qualification and validation, 2001.
2PIC/S. PI 006-3, recommendations on validation master plan[S]. 2007.
3ICH. Q7 GMP for API[ S] . 2000.
4EMA. Note for guidance on process validation[ S]. 2001.
5Parenteral Drug Association (PDA). Sterilizing filtration of liquids, technical report no. 26 [ R ]. 2008.
6EMA. Decision trees for the selection of sterilisation methods (CPMP/QWP/054/98) [S ]. 1998.
7EMA. Annex 1, Manufacture of sterile medicinal products, EU guidelines to good manufacturing practice[S]. 2008.
8FDA. Sterile drug products produced by aseptic processing, guidance for industry [ S ]. 2004.
9BOWMAN FW, I-IOLDOWAKY S. Production and control of a stable penicillinase [J]. Antibiot Chemother, 1960,10:508.
10American Society for Testing and Materials International ( ASTM ). Committee D19. F838-05 standard test method for determining bacterial retention of membrane fihers utilized for liquid filtration [S]. 2005.