CRED Drug-Device Combination Products - Print friendly

5‐9‐2017

Labelling of cryopreserved product (< -120°C)

Tracking and traceability of materials

Starting/Raw Materials & Component Traceability • System to trace starting & raw materials to individual product • Records to facilitate recall

Label & Status Control

ID & Product Tracking

• Product labeling must occur at the time of manufacture • Labels can not stick to frozen bag or vials • Transient warming could damage the product • Information on label can not be updated • Expiry date • Shelf-life extension - new expiry date

• Labels -

• Donor to Consignee (final disposition) and Consignee to donor • Tracking system needed • Unique ID • Ensure consignee has tracking system

controlled physical location & QA status: accepted, rejected, quarantined • Formal paper or electronic inventory control system

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Storage and shipment considerations for ATMPs Tissue procurement Manufacturing Product storage Distribution operations Product use Excursions

Product containers & cell delivery systems

Intravenous Infusion

Systemic Administration

Infusion bag

Sub dermal implantation

Regional Administration

Encapsulation device

Surgical procedure catheter Techniques

Local Administration

Vial with stopper

Stability defines supply chain of final product (fresh/frozen ) 64 64

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