Improvement projects across the business to reduce waste and improve efficiency Develop and execute first stage of FDA Strategy Considerations to extend ISO 13485 scope to additional product lines

1. Overview of Quality Management System

2. 2
Management System Status
2013
• ISO 9001 implemented and achieved – ISO 9001 covers cell line
products and derived reagents
• ISO 13485 implemented and achieved - ISO 13485 covers selected
reagent products (GDNA and FFPE)
Early 2014
• ISO 9001 and ISO 13485 retained and non-conformities reduced
• ISO 13485 with CMDR (Canada) achieved
• Significant improvements seen in the Quality Management System
Mid 2014
• Improvement projects across the business to reduce waste and
improve efficiency
• 21 CFR 820 (US) Strategy in consideration

3. 3
Management System Status
Late 2014
• ISO 9001 and ISO 13485 retained and zero
non-conformities raised
• Further improvements and maturity seen
in the Quality Management System
2015
• Develop and execute first stage of FDA
Strategy
• Considerations to extend ISO 13485 scope
to additional product lines

4. Key drivers for Horizon’s Quality Management System?
1. Productivity/Efficiency
2. Predictability
3. Communication
Productivity/
Efficiency
Communication
QMS
Predictability

5. Product Inspection Flow
Cell Culture
Pellet
Inventory For
Sale
Cell Culture Production Batch Record Inspection
Pellet Production Batch Record Inspection
Generating Bulk Stock
QC to specifications
Temporary Inventory / Stock
Batch Record Inspection
Release For Sale
Three Levels of Inspection
(Independence is aimed
for at all levels)
Second Scientist
Senior Scientist /
QC
QC / Production
Manager
5

6. Non-conformance and Corrective/Preventive Actions
6
Incident Report -
Record observation
- Assess impact
- Complete
corrections
Trend
- Repeat incidents
- Repeat Root
Causes
- Decide to
escalate
Action Report -
Record trends
- Identify
corrective and
preventive actions
- Verify and
monitor
effectiveness
BP-20-03-01 Incident and
Action Management

7. BP-21-01-02
Management
System
Document
Control
7
Document Control
BP-21-01-01
Control and
Retention of
Records
RD-02-10-08
Product
Change
Control
BP-02-10-06
Design
Change
Control

8. Supplier Management and Goods-in Inspection
Perform supplier
8
audits and
continuing
assessment
Supplier
Audit
Schedule
Material
Prioritisation
(Risk Based)
BP-12-01-01
Purchasing &
Supplier
Management
BP-12-02-01 Receipt
of Purchased
Materials
Goods-in Inspection

9. 9
Equipment Control Lifecycle
EQ • Define
requirements
• Approve budget
IQ / OQ
• Test
requirements
• Controls and
training
PQ
• Confirm
process
performance
Routine
Use
INCIDENT OR
BREAK DOWN
Disposal
ROUTINE CALIBRATION/
MAINTENACE