Discussion Forum

Validation according to Annex 15 and FDA requirements

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List of contributions:

• TjDoNRClHlIBC from Namrata (2/28/2012 11:00)
  • RE: TjDoNRClHlIBC from Leidiane (3/30/2012 00:35)
• Stability test from PATRICIA CHAVEZ (2/14/2007 20:50)
  • RE: Stability test from KAMLESH THAKUR (4/10/2008 14:08)
• cleaning validation from Ilyas Patel (11/27/2006 12:42)
  • RE: cleaning validation from Dilip Vaghela (1/31/2007 11:27)
    • RE: RE: cleaning validation from Abhinav (11/4/2012 18:17)
    • RE: RE: cleaning validation from Jenita (12/18/2011 04:07)
  • RE: cleaning validation from Manoj kumar katiyar (12/23/2006 12:12)
• Non viable particle monitoring from Manoj kumar katiyar (11/13/2006 14:04)
  • RE: Non viable particle monitoring from Mike Edgington (11/13/2006 18:56)
• Aseptic Process from Sudhir Kulkarni (6/21/2006 17:32)
  • RE: Aseptic Process from Kaed (12/16/2011 07:49)
  • RE: Aseptic Process from balaji (11/2/2007 13:19)
  • RE: Aseptic Process from Mike Edgington (7/11/2006 14:19)
    • RE: RE: Aseptic Process from Y.S.Reddy (11/12/2006 11:38)
      • RE: RE: RE: Aseptic Process from Manoj kumar katiyar (11/16/2006 14:09)
• Sterilizer from Sudhir Kulkarni (6/21/2006 17:27)
  • RE: Sterilizer from Y.S.Reddy (11/12/2006 11:41)
    • RE: RE: Sterilizer from Manoj kumar katiyar (11/29/2006 07:25)
• Advice needed for Validation or temperature mapping for Large ambient storage area from Ho Xin Hui (5/25/2006 06:23)
  • RE: Advice needed for Validation or temperature mapping for Large ambient storage area from Dick Bonner (6/5/2006 15:57)
• validation of purified water system from A.v.Wijk (3/3/2006 09:47)
  • RE: validation of purified water system from SURESH (2/6/2008 12:53)
  • RE: validation of purified water system from SURESH (2/6/2008 12:53)
  • RE: validation of purified water system from Dick Bonner (3/15/2006 19:42)
    • RE: RE: validation of purified water system from A.v.Wijk (3/22/2006 08:57)
      • RE: RE: RE: validation of purified water system from Dick Bonner (3/27/2006 20:33)
• Validation of Plasmid Copy Number determination from Andrew Lumsden (1/10/2006 14:05)
• glove disinfection validation from Th Mikosch (10/1/2005 10:27)
  • RE: glove disinfection validation from Mike edgington (10/7/2005 13:52)
• AHU-Return Air from Dr. Sirsendu Sukul (9/5/2005 09:55)
  • RE: AHU-Return Air from Manoj katiyar (9/13/2005 18:19)
    • RE: RE: AHU-Return Air from Dr. Sirsendu Sukul (9/26/2005 07:19)
      • RE: RE: RE: AHU-Return Air from Dr.S.N.Gangal (7/21/2007 13:17)
        • RE: RE: RE: RE: AHU-Return Air from sunil (2/4/2008 06:10)
      • RE: RE: RE: AHU-Return Air from Dr.S.N.Gangal (7/21/2007 13:12)
• Computer System Development Methodologies from Paul (8/22/2005 13:01)
• glassware cleaning validation from anna cluet (6/30/2005 18:12)
  • RE: glassware cleaning validation from Y.S.Reddy (11/12/2006 11:51)
    • RE: RE: glassware cleaning validation from Daniel (2/28/2011 14:31)
      • glassware cleaning validation from Colin Shamhuyarira (3/23/2011 15:28)
        • RE: glassware cleaning validation from sunil.patil (11/11/2012 06:46)
        • RE: glassware cleaning validation from murali krishna koppaka (9/29/2011 18:30)
          • RE: RE: glassware cleaning validation from P.V.Rao (5/18/2012 08:13)
            • RE: RE: RE: glassware cleaning validation from Vamsy Mojjada (6/6/2012 17:15)
• HEPA Filter-Validation from Dr. Sirsendu Sukul (6/14/2005 07:03)
  • RE: HEPA Filter-Validation from Suresh kumar.V (10/10/2005 13:46)
  • RE: HEPA Filter-Validation from Mike Edgington (8/2/2005 20:01)
• HEPA Filter-Validation from Dr. Sirsendu Sukul (6/14/2005 07:02)
  • RE: HEPA Filter-Validation from Sudhir Kulkarni (6/21/2006 17:06)
• Testing on finished product from shekhar dabholkar (4/7/2005 12:38)
  • RE: Testing on finished product from ahmad abu rahma (7/24/2007 13:57)
  • RE: Testing on finished product from Richard Bonner (4/26/2005 10:40)
• Room Cleaning Validation from Dr. Sirsendu Sukul (10/11/2004 06:43)
  • RE: Room Cleaning Validation from Happy (10/29/2012 09:47)
  • RE: Room Cleaning Validation from Y.S.Reddy (11/12/2006 10:50)
  • RE: Room Cleaning Validation from PaulS (11/9/2004 02:08)
• Equipment Validation-Pharma Formulation from Dr. Sirsendu Sukul (10/5/2004 07:07)
  • RE: Equipment Validation-Pharma Formulation from sudhir kulkarni (6/21/2006 17:14)
    • RE: RE: Equipment Validation-Pharma Formulation from Missi (9/5/2012 06:21)
  • RE: Equipment Validation-Pharma Formulation from PaulS (10/10/2004 22:36)
• Equipment Validation-Pharma Formulation from Dr. Sirsendu Sukul (10/5/2004 07:07)
• Cleaning Validation from Dr. Sirsendu Sukul (10/4/2004 11:22)
  • RE: Cleaning Validation from Y.S.Reddy (11/12/2006 11:53)
• Process Validation from Dr. Sirsendu Sukul (10/4/2004 11:20)
  • RE: Process Validation from Mike Edgington (10/8/2004 15:26)
• Equipment Validation from Dr. Sirsendu Sukul (10/4/2004 11:04)
  • RE: Equipment Validation from GEORGE KALOGERAS (8/1/2006 14:34)
  • RE: Equipment Validation from PaulS (10/5/2004 02:25)
• Microbiological Specification from Dr. Sirsendu Sukul (6/27/2004 12:48)
  • RE: Microbiological Specification from Mike Edgington (7/5/2004 17:35)
• Retrospective Process Validation from DR. SIRSENDU SUKUL (6/23/2004 11:32)
• CNI Qualification from PaulS (4/28/2004 02:52)
• HEPA filter from Eng. Nabil Hoseh (4/6/2004 10:33)
  • RE: HEPA filter from Mike Edgington (4/14/2004 12:40)
    • RE: RE: HEPA filter from Christophe MARTIN (8/26/2004 15:49)
• Validation of CMDB and Documentum from Peter Demmink (1/29/2004 10:49)
  • RE: Validation of CMDB and Documentum from PaulS (4/6/2004 05:53)
  • RE: Validation of CMDB and Documentum from Dick Bonner (2/6/2004 15:55)
• Cleaning validation samples for API from umesh B.G (9/23/2003 11:11)
  • RE: Cleaning validation samples for API from dick bonner (10/14/2003 17:20)
    • RE: RE: Cleaning validation samples for API from Dr. Ashutosh Kumar Verma (9/17/2007 07:30)
• Role QA in qualification from Sven Van de Ven (4/29/2003 15:54)
  • RE: Role QA in qualification from Dick Bonner (5/21/2003 12:29)
    • RE: RE: Role QA in qualification from Kassie (1/19/2012 14:11)
• sieves validation from Marino gonzalez (10/31/2002 15:55)
  • generic pills from mrcaverta (12/22/2006 09:55)
  • RE: sieves validation from Christian van Munster (10/14/2003 12:15)
• Process validation from Martin Matejka (9/6/2002 13:15)
  • RE: Process validation from george kalogeras (8/1/2006 14:46)
  • RE: Process validation from M.V.Subba Raju (9/22/2005 13:24)
  • RE: Process validation from Doroteja Kirhmajer (9/16/2002 08:54)
    • RE: RE: Process validation from Sudeep (3/25/2012 18:29)
    • RE: RE: Process validation from Karl (9/8/2003 14:25)
• POST MAINTENANCE TESTING from Doroteja Kirhmajer (5/2/2002 10:15)
  • RE: POST MAINTENANCE TESTING from Idalia (12/18/2011 04:30)
  • RE: POST MAINTENANCE TESTING from Dick Bonner (5/9/2002 12:27)
    • RE: RE: POST MAINTENANCE TESTING from Sole (9/2/2012 13:22)
    • RE: RE: POST MAINTENANCE TESTING from Doroteja Kirhmajer (5/14/2002 13:12)
• Viral safety test validation from Paola Gnemi (4/17/2002 11:34)
  • RE: Viral safety test validation from John Taylor (4/22/2002 16:11)
  • RE: Viral safety test validation from Mike Edgington (4/18/2002 17:15)
    • RE: RE: Viral safety test validation from Latesha (12/18/2011 07:23)
• OQ / IQ / Alarm tests from S. Pommeranz (3/25/2002 09:44)
  • RE: OQ / IQ / Alarm tests from sudhir Kulkarni (6/21/2006 17:41)
    • RE: RE: OQ / IQ / Alarm tests from Sanjiv Sharma (7/11/2006 09:17)
  • RE: OQ / IQ / Alarm tests from John Taylor (4/1/2002 12:41)
    • RE: RE: OQ / IQ / Alarm tests from Dick Bonner (4/7/2002 16:16)
      • RE: RE: RE: OQ / IQ / Alarm tests from Oliver Schmidt (4/10/2002 10:03)
        • RE: RE: RE: RE: OQ / IQ / Alarm tests from Dick Bonner (4/14/2002 15:24)
• Risk analysis SOP from Dr G Becker (3/22/2002 08:31)
  • RE: Risk analysis SOP from John Taylor (3/24/2002 14:26)
• Process Validation runs from Dr G. Becker (3/22/2002 08:30)
  • RE: Process Validation runs from John Taylor (3/24/2002 14:11)
    • RE: RE: Process Validation runs from rakesh (12/4/2006 08:17)
• Validation Master Plan from H. Martin (3/21/2002 09:40)
  • RE: Validation Master Plan from Carlos Nadal (12/28/2006 18:52)
  • RE: Validation Master Plan from Luis Viadel (7/23/2004 12:21)
  • RE: Validation Master Plan from Siegfried Schmitt (4/15/2002 12:37)
    • RE: RE: Validation Master Plan from karl (9/8/2003 14:33)
  • RE: Validation Master Plan from John Taylor (3/24/2002 14:37)
• FMEA, Risk Assessment from B. Jentges (3/21/2002 09:39)
  • RE: FMEA, Risk Assessment from dick bonner (4/7/2002 16:12)
  • RE: FMEA, Risk Assessment from Oliver Schmidt (3/27/2002 12:46)
• PQ from Sven Pommeranz (3/20/2002 08:38)
  • RE: PQ from Poetra (5/9/2012 18:17)
  • RE: PQ from PaulS (4/6/2004 05:42)
  • RE: PQ from Siegfried Schmitt (4/15/2002 12:42)
  • RE: PQ from John taylor (3/24/2002 14:22)
    • RE: RE: PQ from Stephen Fitzpatrick (4/15/2002 17:29)
      • RE: RE: RE: PQ from Cactus (12/16/2011 09:17)
      • RE: RE: RE: PQ from Wiebke Herrmann (9/5/2006 17:02)