董巍 新版GMP后的挑战和方案

2010版药品GMP指南-全套6本资料http:/www.yaojia.org/forum.php?mod=viewthread&tid=28747&fromuid=1023,GMP|PallLife Sciencesw/Vivien Dong2010版药品GMP指南-全套6本资料http:/www.yaojia.org/forum.php?mod=viewthread&tid=28747&fromuid=1023DisclaimerThis presentation is the Confidential work product of PallCorporation and no portion of this presentation may be copied,published,performed,or redistributed without the expresswritten authority of a Pall corporate officer.2011 Pall Corporation2010版药品GMP指南-全套6本资料http:/www.yaojia.org/forum.php?mod=viewthread&tid=28747&fromuid=1023 1 2010版药品GMP指南-全套6本资料http:/www.yaojia.org/forum.php?mod=viewthread&tid=28747&fromuid=1023 1P1 P 5 SAL z10-64 5 r F0 z8 z 4 z 5EU GMP Annex 1 Manufacture of Sterile Medicinal Products(2008)83.Where possible,heat sterilisation is the method of choice.2010版药品GMP指南-全套6本资料http:/www.yaojia.org/forum.php?mod=viewthread&tid=28747&fromuid=1023,GMP 1SP 1 1 4 0.22Im z 8 4z z 5 4x 9 4 x 42010版药品GMP指南-全套6本资料http:/www.yaojia.org/forum.php?mod=viewthread&tid=28747&fromuid=1023GMP Annex 1 Manufacture of Sterile Medicinal Products(2008)110.P&-44 Q 5 4 111.Due to the potential additional risks of the filtration methodas compared with other sterilization processes,a secondfiltration via a further sterilised micro-organism retaining filter,immediately prior to filling,may be advisable.The final sterilefiltration should be carried out as close as possible to the fillingpoint.2010版药品GMP指南-全套6本资料http:/www.yaojia.org/forum.php?mod=viewthread&tid=28747&fromuid=1023 5 Decision Trees for the Selection of Sterilisation Methods(CPMP/QWP/O54/98)5 Introduction 4&5 5 5 z 1 4/:Aqueous Products)3 z F(Non-aqueous Liquid,Semi-solid or Dry Powder Products)2010版药品GMP指南-全套6本资料http:/www.yaojia.org/forum.php?mod=viewthread&tid=28747&fromuid=1023 :?4?3 1 2010版药品GMP指南-全套6本资料http:/www.yaojia.org/forum.php?mod=viewthread&tid=28747&fromuid=1023 3 z F=?r z 4=?3 4 5 F 4Z 5 F Z F ijklmnopq F 1 8 2010版药品GMP指南-全套6本资料http:/www.yaojia.org/forum.php?mod=viewthread&tid=28747&fromuid=1023|9:F1#$%(e r 4 z ,#$%,r&JKLMLJMLa4“42010版药品GMP指南-全套6本资料http:/www.yaojia.org/forum.php?mod=viewthread&tid=28747&fromuid=1023,GMP LQ S P 1 14 ghiiIj z 8 4z z 5 4x 9 4 x 42010版药品GMP指南-全套6本资料http:/www.yaojia.org/forum.php?mod=viewthread&tid=28747&fromuid=1023 0.2 m 0.2 m 2010版药品GMP指南-全套6本资料http:/www.yaojia.org/forum.php?mod=viewthread&tid=28747&fromuid=1023 5 4FDA 1 4 4107/cm2 P.diminuta|4(FDA 1 1987)LRV z7/cm2 20102010版药品GMP指南-全套6本资料http:/www.yaojia.org/forum.php?mod=viewthread&tid=28747&fromuid=1023 k /1;:2010版药品GMP指南-全套6本资料http:/www.yaojia.org/forum.php?mod=viewthread&tid=28747&fromuid=1023,FGH x 3 3 3 E z 5 4 P 5 1/P 4Y 1 Q/F z 4r 42010版药品GMP指南-全套6本资料http:/www.yaojia.org/forum.php?mod=viewthread&tid=28747&fromuid=1023,GMP LQ P 4 4 3 z t-4S 1 P r x 4 r z 4 P r P P 1 a42010版药品GMP指南-全套6本资料http:/www.yaojia.org/forum.php?mod=viewthread&tid=28747&fromuid=1023GMP Annex 1 Manufacture of Sterile Medicinal Products(2008)112.Fibre-shedding characteristics of filters should be minimal.113.The time taken to filter a known volume of bulk solution and thepressure difference to be used across the filter should be determinedduring validation and any significant differences from this during routinemanufacturing should be noted and investigated.Results of thesechecks should be included in the batch record.114.The same filter should not be used for more than one working dayunless such use has been validated.115.The filter should not affect the product by removal of ingredientsfrom it or by release of substances into it.2010版药品GMP指南-全套6本资料http:/www.yaojia.org/forum.php?mod=viewthread&tid=28747&fromuid=1023 Q,Lz _ saline lactosebroth,SLB zF -Q,LL=V*VVEVVV-Q Q=QV=1 V*=z E=QQ-QQ 5 z F 5 K Q,LQ,L-Q-QVEEEQ,LQ-QTOC PDA TR26-Q2008 Sterilizing Filtration of Liquids“2010版药品GMP指南-全套6本资料http:/www.yaojia.org/forum.php?mod=viewthread&tid=28747&fromuid=1023 1 r k 2010版药品GMP指南-全套6本资料http:/www.yaojia.org/forum.php?mod=viewthread&tid=28747&fromuid=1023 1 2010版药品GMP指南-全套6本资料http:/www.yaojia.org/forum.php?mod=viewthread&tid=28747&fromuid=1023 60 Q60-70:r 0.45 m :80:0.2 m Q -ASTM F838-83-1987 FDA 1 90:0.1 m-1998 PDA F 2600 Serial/Redundant/Double filtration-2003 EC GMP 1-2004 FDA 1 2010版药品GMP指南-全套6本资料http:/www.yaojia.org/forum.php?mod=viewthread&tid=28747&fromuid=1023Serial/Redundant/Double Serial:events occurring sequentially,.w Double:two together or sequentially P z.Redundant:Superfluous,not needed Ref.s:,American Heritage Dictionary2010版药品GMP指南-全套6本资料http:/www.yaojia.org/forum.php?mod=viewthread&tid=28747&fromuid=1023Serial/Redundant/Double 2010版药品GMP指南-全套6本资料http:/www.yaojia.org/forum.php?mod=viewthread&tid=28747&fromuid=1023 Note for guidance on Manufacture of the Finished DosageForm(1996)t F 7.Special Items(/w-)z /7 Q 4&10 CFU/100 ml z 4 4 Z -8 4 42010版药品GMP指南-全套6本资料http:/www.yaojia.org/forum.php?mod=viewthread&tid=28747&fromuid=1023 Serial Filtration/:P 1 4 2010版药品GMP指南-全套6本资料http:/www.yaojia.org/forum.php?mod=viewthread&tid=28747&fromuid=1023/Serial FiltrationP 1 4 :BA 2