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Introduction to Pharmaceutical Quality Systems - Coggle Diagram
Introduction to Pharmaceutical Quality Systems
Why
Historical context
Regulatory framework
ICH - why it exists
What
What is a PQS
Regulatory bodies
What is quality
What distinguishes it from a QMS
Structure
Documentation of specs, SOPs and records
Supported by validated equipment, processes and trained/committed operators
Elements
Objectives
How
Process Performance and Product Quality Monitoring
Corrective Active and Preventative Action
Change Management
Review of Process Performance and Product Quality
Design of a PQS
Proactive
CAPA
Self-Inspections
Change Management
Risk Assessments
Reactive
Deviation Management
OOS
Senior Management Responsibilities and Capacity
Tools
Electronic Systems
Paper-based Systems
Data analytics