2. Pharmaceutical Manufacturing Facility
Keep it Young
Regulatory
Quality
1
OARO-10 Sep 2017PDA-2017
Review &
monitor
• Recalls & Lot
Acceptance
Rates,
Trend data &
keep an eye on
• Increase in
Deviations,
OOS, CAPAs,
complaints,
audit
observations
Trace and track
increase in
• Change in
Process/
equipment/
facility
OOS: Out of Specification (Results), CAPA: Corrective & Preventive Action
3. Pharmaceutical Manufacturing Facility
Keep it Young
Facility
Equipment
2
OARO-10 Sep 2017PDA-2017
WHEN
Finishing attracts
Parts are not available
Technology is obsolete
INCREASE
Maintenance & Downtime
Contamination issues
Environmental Monitoring
4. Pharmaceutical Manufacturing Facility
Keep it Young
Process
Supply
3
OARO-10 Sep 2017PDA-2017
Materials
• Supplier is
lethargic or
losing interest
Capacity
• Increase in
market
demand
Change
• ↓ Process yield
• ↑ deviations
• ↑ Downtime
• ↑ Failures
• ↑ Variability
• ↑ Rework