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q10

q10

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Published by kvcchakrapani

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Published by: kvcchakrapani on Mar 28, 2010
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07/26/2010

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Q10
 
P
HARMACEUTICAL
Q
UALITY
S
YSTEM
 
This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's)current thinking on this topic. It does not create or confer any rights for or on any person and doesnot operate to bind FDA or the public. An alternative approach may be used if such approachsatisfies the requirements of the applicable statutes and regulations. If you want to discuss analternative approach, contact the FDA staff responsible for implementing this guidance. If youcannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
For questions regarding this draft document contact (CDER) Joseph Famulare at301-827-8910, (CBER) Christopher Joneckis at 301-435-5681, or (ORA) DianaAmador-Toro at 973-331-4915.
 
 
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICALREQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMANUSE
D
RAFT
C
ONSENSUS
G
UIDELINE
 
P
HARMACEUTICAL
Q
UALITY
S
YSTEM
 
Q10
Current
Step 2 
versiondated 9 May 2007
 At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Steering Committee to the regulatory authorities of the three ICH regions (the European Union, Japan and the USA) for internal and external consultation, according to national or regional procedures.
 
 
 
Q10Document HistoryCurrent
Step 2
version
FirstCodificationHistory DateNewCodification
November2005
 Q10 Approval by the Steering Committee under
Step 2 
 and release for public consultation.9 May 2007Q10

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