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PAT, cGMP for the 21st Century and ICH Q8, Q9, Q10

PAT, cGMP for the 21st Century and ICH Q8, Q9, Q10

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Published by Narendrakumar

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Published by: Narendrakumar on Jan 08, 2009
Copyright:Attribution Non-commercial

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12/18/2012

 
a Novartis company
PAT, cGMPfor the 21
st
Century, andICH Q8, Q9, Q10
Ajaz S. Hussain, Ph.D.Vice President & Global Head BiopharmaceuticalDevelopment Sandoz, Inc.10 September 2007, The British PharmaceuticalConference 2007, Manchester, UK.
 
Outline
2PAT, cGMP 21
st
Century/ Ajaz Hussain/ 10 September 2007
The FDA Initiative: Vision Vs. Reality
The “desired state”
Journey towards the “desired state”: Where are we today?
 
A Transforming Agenda
3PAT, cGMP 21
st
Century/ Ajaz Hussain/ 10 September 2007
PAT Initiative
 
C    r   i    t   i    c   a  l     P    a  t   h    I    n  i    t   i    a  t   i    v   e  
“Desired State”
2001
2   0   0   2   
2     0     0     3     

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