Service area · Entrepreneurial pharmacy management

Plan, authorise and launch a pharmacy-owned pharmaceutical wholesaler

A dedicated wholesale operation can extend sourcing, direct purchasing, supply and B2B models, but it is not merely an extra pharmacy process. It is a separately authorised, GDP-governed business with its own accountability.

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Section 52a AMG · GDP · wholesale authorisation

A pharmacy-owned pharmaceutical wholesaler as a complete operating model

A dedicated wholesale operation can extend sourcing, direct purchasing, supply and B2B models, but it is not merely an extra pharmacy process. It is a separately authorised, GDP-governed business with its own accountability.

tiger.PHARMA combines the services commonly offered separately in the market – licence support, QMS templates, Responsible Person support and pre-audits – with commercial modelling, facilities, logistics, systems, procurement, customer processes and controlled launch.

Feasibility and business case

Use cases, assortment, volumes, margin, investment, people and working capital are tested before major spend.

  • Direct purchasing, specialist ranges and partner supply
  • Supplier, customer and volume model
  • Investment, operating cost and working capital
  • Base, target and downside scenarios

Separation from the pharmacy operation

Roles, stock, contracts, movements, systems and responsibilities are separated while controlled interfaces remain workable.

  • Activity and licence matrix
  • Organisation and responsibility model
  • Separate stock, records and counterparties
  • Conflicts, internal supply and escalation

Authorisation and authority project

The operating model becomes a structured application and evidence roadmap aligned with the competent authority and authorised advisers; approval cannot be guaranteed.

  • Scope and application documentation
  • Facility, zoning, people and operating concept
  • Milestones and authority communication
  • Readiness review before inspection

Responsible Person and GDP governance

The RP is embedded early with real authority, resources, deputy arrangements and independent escalation.

  • Role profile, selection and onboarding
  • Delegation and approval matrix
  • Management review and quality KPI
  • Optional search and continuing support

GDP QMS and controlled documents

A lean, business-specific QMS replaces a disconnected template pack.

  • Quality manual, process map and SOPs
  • Supplier and customer qualification
  • Deviation, CAPA, change, returns and recall
  • Training, self-inspection and document upkeep

Warehouse, transport and qualification

In-house and outsourced activities form one controlled GDP chain.

  • Layout, quarantine, security and traceability
  • Temperature mapping, monitoring and calibration
  • Route, vehicle and packaging qualification
  • Quality agreements, SLA, audits and partner KPI

ERP, WMS, MSV3 and data

Master, batch, order and customer data are designed for traceability and scale, then tested end to end.

  • ERP and WMS requirements
  • PZN, master, batch and serialisation data
  • MSV3 ordering and status responses
  • Access, logs, data quality and continuity

Pre-audit, launch and managed support

Mock inspections and live process tests bridge documentation and routine operation.

  • GDP gap analysis and mock inspection
  • CAPA and effectiveness evidence
  • Pilot, go-live and hypercare
  • Ongoing QMS, audits, training and change support

FAQ

Frequently asked questions

When does a pharmacy need wholesale authorisation?

That depends on the planned activities, flows and customers. The boundary between pharmacy activity and authorised wholesale distribution should be clarified early with the competent authority and authorised advisers.

Can a wholesaler share a building with the pharmacy?

Any arrangement requires an authority-accepted separation of facilities, stock, processes, records and accountability. The concrete model must be addressed in the facility and operating concept.

Does tiger.PHARMA only provide an application and SOPs?

No. Support can cover feasibility, authorisation, QMS, RP, warehouse, transport, systems, qualification, mock inspection, launch and ongoing operation, while remaining modular.