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Q10 QMS (MANAGEMENT RESPONSIBILITY (Management Commitment, Quality Policy…
Q10 QMS
MANAGEMENT
RESPONSIBILITY
Management Commitment
Quality Policy
Quality Planning
Resource Management
Internal Communication
Management Review
Mnmgt of
Outsorced Activities
and
Purchased Materials
Mngmt of Change
in
Product Ownership
PHARMACEUTICAL QMS
Scope
Relationship with others
ICH Q10 Objectives
Knowledge Mngmt and
Quality Risk Management
Design and Content Considerations
Quality Manual
CONTINUAL IMPROVEMENT OF QMS
Management Review of
PQMS
Monitoring Internal and
External Factors
Outcomes of Management Review
and Monitoring
CONTINUAL IMPROVEMENT
OF PROCESS PERFORMANCE
AND PRODUCT QUALITY
Lifecycle Stage Goals
PQMS Elements