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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
Primary packaging, blinding and secondary packaging
Packaging processes for P1 – P4 studies
Packaging processes for P1 - P4 studies
Primary packaging
Blister packs (PVC/PVDC, Aclar, Alu/Alu)
Aluminium seal bags
Sachet filling
Bottle filling with/without induction seal
Blinding
Blisters containing different dosages/products
Blister cards
Tube-in-tube blinding
Secondary packaging
Adapted designs with/without printing
Shipping packages
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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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