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
Objectives
Supported by validated equipment, processes and trained/committed operators
Elements
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
Reactive
CAPA
Self-Inspections
Change Management
Deviation Management
OOS
Senior Management Responsibilities and Capacity
Tools
Electronic Systems
Paper-based Systems
Data analytics
Risk Assessments