Regulatory Approaches in Site Selection for Inspections

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Obaid Ali / Roohi B. Obaid

Discussion Forum on ICH-Q9 at ICCBS, University of Karachi on 23 July 2017

Leadership & Management

Q-9 and Regulatory Approaches in
Site Selection for Inspection
Dr. Obaid Ali
Deputy Director, DRAP
Member ISPE, PDA
Discussion Forum on
ICH-Q9

Prioritization of Manufacturing Site for Inspection

New Facility
Old with reported
recalls
Old without recalls

Severity Probability Detectability
New
Facility
Old with
reported
recalls
Old without
recalls

Severity Probability Detectability
Paracetamol
Metoprolol
Pyridoxine
HCl

Risk Management is Universal
Strategic
• Competitive
advantage
Operational
• Company
viability
Financial
• Shareholders
harm
Compliance
• Patient harm
ICH Q9
Influence

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