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2.1:
Contract Manufacturing
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2.2:
Innovation & Development
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2.3:
Marketing Authorisation
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2.4:
Material Procurement
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2.5:
Production
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2.6:
Logistics & Distribution
Controlled storage
Storage from -70°C Freezers – 25°C High-rack warehouse
Storage characteristics
15C° - 25°C: High-rack warehouse with > 7500 pallet spaces
2C° - 8°C: Refrigerated rooms with temperature mapping
-70°C: Freezers with emergency power supply
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1.5.2:
Clinical Trial Materials
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1.5.2.1:
Bulk manufacture and procurement of investigational products
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1.5.2.2:
Primary packaging, blinding and secondary packaging
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1.5.2.3:
Labelling according to Annex 13
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1.5.2.4:
Controlled storage
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1.5.2.5:
Distribution
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1.5.2.6:
Quality planning, quality control and QP release
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1.5.2.7:
Project planning, coordination and communication
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