Define the jurisdiction and distribution activity first

GDP preparation starts with the product category, warehouse sites, suppliers, recipients, carriers and contracted operations. Finished human medicines, active substances and veterinary products should not be treated as one regulatory route. For medicinal-product wholesale distribution in the EEA, the national competent authority handles authorisation and inspection, as explained by EMA. A Turkish warehouse application requires a separate check of the relevant Provincial Health Directorate procedure and applicable rules. A general private certificate does not identify or replace that route.

Keep outsourced transport inside the process map

Consider a hypothetical distributor that hands consignments to a carrier which uses a second transfer hub. A warehouse temperature log alone does not explain conditions at that hub. Add transfer, waiting and delivery steps, identify their owners, and agree how records and deviations reach the responsible team. Use the storage conditions applicable to the actual product rather than publishing one temperature range for all medicines. This planning example does not describe a Kayra customer or establish that a consignment is safe.

Separate preparation deliverables from regulatory decisions

Kayra can support a gap review, responsibility mapping and preparation of records within an agreed consultancy scope. The engagement cannot grant a wholesale authorisation, issue an official inspection finding or guarantee a regulatory GDP certificate. Before commissioning work, write down the country, activity, competent authority and any separate assessment decision owner. Budget warehouse preparation, transport qualification and official procedures separately. Readiness work may reveal that more operational evidence is needed before an application can proceed.

Official references and limits

References checked on 3 October 2026. European and Turkish routes are distinguished; the worked examples explain preparation only.