Guidance for Industry Q10 Pharmaceutical Quality System

 Management Review (2.6) ............................................................................................................ 7
G.  Management of Outsourced Activities and Purchased Materials (2.7).................................... 7
H.  Management of Change in Product Ownership (2.8) ................................................................. 8
IV.
CONTINUAL IMPROVEMENT OF PROCESS PERFORMANCE AND 
PRODUCT QUALITY (3) ............................................................................................... 8
A.  Lifecycle Stage Goals (3.1) ............................................................................................................ 8
B. Pharmaceutical Quality System Elements (3.2) .......................................................................... 9
V.
CONTINUAL IMPROVEMENT OF THE PHARMACEUTICAL QUALITY 
SYSTEM (4) .................................................................................................................... 13
A. Management Review of the Pharmaceutical Quality System (4.1).......................................... 13
B. Monitoring of Internal and External Factors That Can Have an Impacton the 
Pharmaceutical Quality System (4.2) ......................................................................................... 13
C. Outcomes of Management Review and Monitoring (4.3)......................................................... 14
VI. 
GLOSSARY (5)............................................................................................................... 15
Annex I: Potential Opportunities To Enhance Science- and Risk-Based Regulatory 
Approaches *............................................................................................................... 18
Annex 2: Diagram of the ICH Q10 Pharmaceutical Quality System Model…..……………19
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