Service area · Wholesale distribution of medicinal products

External Responsible Person for pharmaceutical wholesale distribution

Pharmaceutical wholesale works only when transport, storage, accountability and data are managed as one audit-ready system.

Review GDP structure and accountability

GDP · accountability · integration

External Responsible Person (RP)

Pharmaceutical wholesale works only when transport, storage, accountability and data are managed as one audit-ready system.

We connect GDP processes with operational reality: from an external Responsible Person through transport and warehouse integration to training and inspection readiness.

tiger.PHARMA Kompetenz

Topics we master

Authority and duties of the Responsible Person

Qualification, contractual authority, information access, capacity and deputy arrangements must fit the real operation.

  • Role description
  • Deputy and availability
  • Independent quality decisions
  • Interfaces with management, QMS and operations

Integrate transport and storage

Routes, vehicles, packaging, zones, partners and data flows are qualified and controlled according to risk.

  • Temperature mapping, route and packaging qualification
  • Inbound, quarantine, batch and returns processes
  • Partner qualification and documented interfaces

Embed the Responsible Person

The Responsible Person receives clear tasks, decision routes and evidence – internal or external, never merely nominal.

  • Role model, cover and release rules
  • GDP gap analysis and action plan
  • Support for licences, audits and authority communication

Make teams audit-ready

Training, SOPs, deviations, CAPA and self-inspections become part of daily operation.

  • Role-based GDP training
  • Document control and evidence
  • Mock audits and effective CAPA