Guidance for Industry Q10 Pharmaceutical Quality System

A. Scope (1.2)....................................................................................................................................... 2
B.  Relationship of ICH Q10 to Regional GMP Requirements, ISO Standards,
and ICH Q7 (1.3)............................................................................................................................ 3
C. Relationship of ICH Q10 to Regulatory Approaches (1.4)......................................................... 3
D. ICH Q10 Objectives (1.5) .............................................................................................................. 3
E.  Enablers: Knowledge Management and Quality Risk Management (1.6) ............................... 4
F. Design and Content Considerations (1.7) .................................................................................... 4
G. Quality Manual (1.8)...................................................................................................................... 5
III. 
MANAGEMENT RESPONSIBILITY (2)...................................................................... 5
A. Management Commitment (2.1)................................................................................................... 5
B. Quality Policy (2.2)......................................................................................................................... 6
C. Quality Planning (2.3).................................................................................................................... 6
D. Resource Management (2.4).......................................................................................................... 7
E.  Internal Communication (2.5) ...................................................................................................... 7
F.