- Published
- Updated
- Sources checked
A shipment booking should follow a reconciled import plan. Product descriptions that differ between the study dossier, proforma invoice and logistics instructions can create avoidable queries and accountability gaps.
Identify the product and route
TİTCK publishes an import application route and forms for investigational and auxiliary medicinal products. Check the current materials for the specific product and transaction. Clinical study permission and an import-related decision address different steps; do not assume that one document completes every supply-chain requirement.
Create a shipment reconciliation sheet
Our recommended reconciliation sheet links study identifier, product name, presentation, planned quantity, importer and destination. Add the document owner for each field. When a document legitimately uses a different description, explain the relationship rather than silently changing the manufacturer's information or making unsupported equivalence assumptions.
Check before freight release
- Reconcile product identity and quantities across the application, invoice and supply plan.
- Confirm the current import documentation and relevant decision before dispatch planning.
- Check receiving facilities, temperature monitoring, shipment contact and excursion escalation.
- Link each receipt to study accountability records without exposing treatment allocation.
Keep customs and clinical release distinct
Customs clearance does not establish that stock is suitable for participant use. Review receipt condition, temperature evidence and any sponsor release requirements before dispensing. Record damaged or uncertain stock separately while the authorized quality assessment proceeds.
Frequently asked questions
- Can a courier decide whether the shipment is study-ready?
- The courier supports transport; regulatory, quality and clinical release responsibilities remain explicitly assigned.
- Should import quantities mirror the whole protocol enrollment?
- Use a documented supply calculation that accounts for presentation, visits, buffer assumptions and planned shipments.